Adverum Biotechnologies, Inc. is hiring a Remote Director Senior Clinical Development
\nThe Director/Senior, Clinical Development will provide scientific and technical expertise for assigned clinical programs and will bring experience in designing and conducting clinical trials. This position has primary responsibilities for setting strategy across the clinical development program, oversight of strategic study design, study start up, CRO and vendor management, clinical data and safety monitoring, analysis and reporting of studies. \n\n\n\nWhat you'll do: \n* Contribute as team leader and author in protocol development, clinical study reports, investigator brochures, periodic safety update reports, international regulatory submissions, interactions with US and Global Health Authorities\n* Writes and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, contributes to scientific publication of study results\n* Serves as CD liaison/point-of-contact for inquiries from clinical operations, clinical research organizations (CROs), etc., collaborates with others in the review of safety narratives and other safety-related guidelines and documentation\n* Represents CD in sub-teams and addresses CD study or other program-specific questions, develops and provides input for clinical presentation slides and other materials for meetings and ongoing communication\n* Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, health authorities, scientists and KOLs, as well as internal groups, including regulatory research, operations, legal and business development\n* Participates in ongoing enhancements and development of team processes, structures, and tools\n* Develops and mentors study team members\n\n\n\nAbout you: \n* MD, PhD or OD required; PharmD with relevant experience may be considered\n* 5-10 years of clinical research and/or clinical development experience within the pharmaceutical or biotech industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of fore mentioned.) Gene therapy and/or ophthalmology (retina) experience preferred.\n* Ability to proactively predict issues and solve problems\n* Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix team\n* Diplomacy and positive influencing abilities\n* Committed to developing and mentoring team \n* Therapeutic area knowledge relevant to mechanism of action and retinal drug development\n* Understanding of US and Global Regulatory requirements\n\n\n\n\n$225,000 - $275,000 a yearThe salary range for this position is $225,000 USD to $275,000 USD annually, with the opportunity to earn an annual bonus. This salary range is an estimate, and the actual salary may vary based on a candidate’s qualifications, including education, length of experience, location, and market data. Employees in this position are eligible to participate in the applicable Company equity incentive award plan. The amount of incentive varies and is subject to the terms and conditions of the plan. Employees in this position are eligible to participate in the Company’s standard employee benefit programs, which currently include the following: medical, dental, vision, 401k, STD/LTD, life and accident insurance, and either paid time off or flexible paid time off.\n\nAbout Us\nAdverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.\n\n\nAt Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self. We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation\n\n\n\n \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Senior and Legal jobs that are similar:\n\n
$60,000 — $145,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nRedwood City, CA
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Synthego is hiring a Remote Senior Strategic Account Manager
\nDo you believe that bioengineering represents the future of medical diagnostics and therapies, with CRISPR/gene editing serving as just the initial breakthrough? We are seeking an experienced, consultative sales professional to join our team, someone who finds inspiration in our mission and can contribute to our established start-up's collaborative, dynamic, and innovative culture. We would like to hear from you if you're enthusiastic about articulating the value of Synthego's cutting-edge platform technologies.\n\n\nAs a Senior Strategic Account Manager, you'll play a pivotal role in driving the growth of our Cell and Gene Therapy business by positioning our Research Use, IND enabling, and Clinical product portfolios. You'll identify, nurture, and grow key client relationships in this position. As an individual contributor, you'll actively engage in outbound sales and prospecting initiatives while collaborating closely with our internal support teams to ensure seamless execution. This role offers an exciting opportunity to directly impact and drive our business forward in the rapidly evolving biotech landscape."\n\n\n\nWhat You'll Do: \n* Serve as the primary point of contact for existing and new accounts ordering Synthego’s RUO, IND enabling, and GMP product lines for the Western US Region \n* Conduct prospecting activities to build a funnel for preclinical and clinical business.\n* Identify clinical upsell opportunities and drive revenue growth.\n* Own the entire opportunity funnel, from opportunity creation to purchase order receipt, while collaborating with the RUO/GMP Product, Quality, and Operations teams.\n* Provide customer and market feedback to the product management and marketing teams to support the expansion of the product roadmap and commercial strategies \n* Leverage emotional and social intelligence to effectively interact with internal and external customers, fostering positive relationships and driving team collaboration across various functions.\n* Learn and evangelize the value proposition of Synthego’s Bench to Clinic synthetic biology products, supporting and improving the cell therapy process through data-driven decisions.\n* Focus on revenue growth, with the goal of establishing Synthego as the primary supplier for genome editing products and services.\n* Continuously build strong relationships with established commercial companies, non-commercial institutions, and universities with cell therapy programs, from bench scientists to senior leadership.\n* Map account structures, including functional areas and personnel, and identify and manage client profiles critical to closing a deal – influencers, budget owners, decision-makers, executive sponsors, etc.\n* Travel approximately 25% of the time for on-site customer meetings.\n\n\n\nAbout You: \n* 5+ years key account / large corporate technical sales experience in biotechnology / Life Sciences or a cell therapy company.\n* Strong experience in sales process management and professional sales techniques (e.g. Challenger, SPIN, Miller Heiman), negotiating 5-8 figure contracts and supply agreements, developing and executing strategic and tactical plans for account growth\n* Strong existing network of contacts and working relationships within large biopharma accounts within your assigned territory that can be leveraged to find the ideal customers for Synthego’s GMP product and service offering\n* Strong working knowledge of the Cell and Gene Therapy process\n* Deep cell biology knowledge needed to understand the customer research focus. Able to find areas of fit with the Synthego platforms, manage the technical conversation and sales process. Note that Synthego does not use an FAS support model.\n* Collaborate closely with Marketing, Sales Operations, Product Management, Technical Support, Research, Operations, and other functions to optimize the balance between customer needs and Synthego capabilities.\n* Comfortable operating with uncertainty, the fast-paced and constant evolution of a start-up company, and competitive environments\n* Highly detail-oriented and needed to manage within a regulatory / GMP environment. \n* Strong verbal and written communication and presentation skills\n\n\n\nNice to Haves: \n* 10+ years overall technical sales experience in an FDA regulated market\n* Prior experience with GMP products and / or working knowledge of regulatory requirements of API in US and EU (i.e. ICH Q7).\n* Previous experience working as a bench scientist or researcher in cell therapy\n* Hands-on experience with CRISPR or genome engineering / SynBio products/services\n* Advanced degree in a Life Science field\n\n\n\nCompany Perks & Benefits \n* Equity options \n* Medical, dental, and vision benefits\n* 401k Program\n* Paid parental leave\n* Flexible paid time off\n\n\n\n\n$140,000 - $160,000 a yearBase salary listed is dependent on experience. This role includes quarterly commission bonuses.\nThe company does not provide immigration sponsorship for this position.\n\nAbout Us\n \nSynthego is a genome engineering company that enables the acceleration of life science research and development in the pursuit of improved human health.\n\n\nThe company leverages machine learning, automation, and gene editing to build platforms for science at scale. With its foundations in engineering disciplines, the company’s platforms vertically integrate proprietary hardware, software, bioinformatics, chemistries, and molecular biology to advance basic research, target validation, and clinical trials.\n\n\nBy providing both commercial and academic researchers and therapeutic developers with unprecedented access to cutting-edge genome engineering, Synthego is at the forefront of innovation, accelerating the development of truly engineered biology. \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to API, Senior, Marketing and Sales jobs that are similar:\n\n
$55,000 — $100,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nRedwood City, CA
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
\nTo support the continued growth of our clinical development capabilities, MindMed is seeking an experienced Data Manager or Senior Data Manager to oversee outsourced studies and be responsible and accountable for managing all Data Management deliverables at a consistently high standard concerning cost, quality, and timelines for all assigned indications within one or more Global Clinical Program(s)/Project(s).\n\nAdditionally, the position would involve managing Real-World Data management assets, including anonymized Electronic Health Records, Medical Claims, patient registries, national surveys, and other emerging data types, enabling company scientists to maximize the use of data for a wide range of applications. They will also manage and catalog Clinical data assets, including historical and ongoing clinical trial data.\n\nResponsibilities:\n\n\n* Serve as DM lead managing assigned study project(s) ensuring overall deliverables/timelines and vendor responsibilities are met and providing oversight of CROs, and other vendors\n\n\n\n\n\n* Represent Data Management on cross-functional study teams\n\n* Oversee multiple concurrent studies while participating in special projects or process improvement initiatives\n\n* Translate clinical protocols into electronic case report forms and develop in conjunction with CRO DM the associated data validation specifications (e.g., edit checks, custom functions and reports)\n\n* Work with multiple external data vendors and facilitate importation of multiple data types into MindMed’s database\n\n\n\n\n\n* Facilitate UAT for database builds and migrations to manage any impacts from mid-study updates to the EDC database and other data collection systems\n\n* Perform data reviews for quality issues, identify general data trends and facilitate data review meetings with relevant cross-functional team members\n\n* Develop technical specifications for data management programming and communicate needs to data management and other technology partners.\n\n* Perform ongoing review of study documentation in the trial master file (TMF) to always ensure audit readiness.\n\n* Participate in Protocol Deviation review meetings and other data cleaning activities.\n\n\n\n\nRequirements:\n\n\n* Bachelor's degree or equivalent\n\n* 3+ years of direct experience in clinical data management within the biotech or pharmaceutical industry\n\n* Proficient in multiple EDC platforms (InForm, RAVE, Oracle Clinical, or similar) and IRT, with strong understanding of database design, database concepts and related processes (database builds, updates, locks, etc.)\n\n* Knowledge of ePRO/eCOA instruments and their use in clinical studies.\n\n* Working knowledge of CDSIC Standards\n\n* Knowledge of international guidelines (ICH-GCP) for the conduct of clinical research projects\n\n* Knowledge of compliance, privacy, and safety pertinent to real-world data analytics\n\n* Ability to multi-task, work independently, and act with appropriate accountability\n\n* Readily adapt to new environment, technologies, and processes\n\n* Strong teamwork and collaboration skills\n\n* Excellent written and verbal communication skills\n\n\n\n\nDesired Skills:\n\n\n* Experience in data management or analysis using biomedical/patient health data/real world data/clinical data/novel data streams\n\n* Experience with Data hub platform and interfaces\n\n* Experience in manipulating large amounts of data\n\n* Experience working with privateb and sensitive personal information\n\n* Medidata accreditation\n\n* Experience with data visualization tools (eg, TIBCO Spotfire, elluminate, Power Bl, Tableau, SAS JMP etc.)\n\n* Computer programming skills in Python/Pyspark, R, SQL\n\n* Experience with cloud and high-performance computing environments (AWS, GCP)\n\n\n\n\nWorking Conditions and Travel:\n\n\n* This is a 100% remote position with ~10% travel requirement based on business needs\n\n\n\n\nThe starting base pay range for this position is $114,000.00 - $148,520.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location.\n\nEmployees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:\n\n\n* 100% paid health benefits including Medical, Dental and Vision for you and your dependents\n\n* 401(k) program with company match and immediate vesting\n\n* Flexible time off\n\n* Generous parental leave and some fun fringe perks!\n\n\n\n\n \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Travel, Cloud and Senior jobs that are similar:\n\n
$60,000 — $110,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nDurham, North Carolina, United States
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
IMVT Corporation is hiring a Remote Senior Manager IT Systems Admin
\nOrganizational Overview:\n\nImmunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.\n\nThe Role:\n\nImmunovant is seeking an experienced IT System Administrator and Architect for our Veeva platform. In this role you will partner with Veeva and the business stakeholders to design, develop, implement and support Veeva solutions aligned with the best practices. The individual in this position will have the unique opportunity to participate in the rapid growth of a biotech startup.\n\nKey Responsibilities: \n\n\n* Understand business requirements and convert them into functional and non-functional requirements\n\n* Lead end-to-end solutioning for Veeva platform in partnership with the business stake holders and third-party service providers. Configure and troubleshoot lifecycle, workflows, documents, and objects\n\n* Setup and manage document type tree/ hierarchies\n\n* Design and administer security roles including Dynamic Access Control (DAC) records as appropriate\n\n* Define and manage user access provisioning and de-provisioning for the Veeva platform\n\n* Manage Veeva platform and end-user licensing in partnership with the business/ functional stakeholders\n\n* Act as single point of contact for resolution of Veeva platform issues by coordinating with the business, IT Managed Services Provider (MSP), Veeva Application Management Services (AMS) and other third-party service providers\n\n* Analyze, implement, and document change and service requests.\n\n* Manage high priority requests and application downtime (planned & unplanned)\n\n* Ensure all Veeva modules remain fully validated during scheduled updates\n\n* Mentor and train functional area engagement teams on Veeva platform adoption.\n\n\n\n\nRequirements:\n\n\n* 7 to 10 years of experience at a life sciences, biotech, or pharmaceutical company providing business analysis and application implementation/ support in a fast-paced, demanding environment\n\n* Subject matter expertise in at least two Veeva Vault modules such as QualityDocs, RIM, eTMF, MedComms and PromoMats; experience in at least one of the regulated Veeva Vault modules a must.\n\n* Experience with Veeva CRM strongly preferred\n\n* At least two full life cycle Veeva Vault implementations\n\n* Certifications in Veeva Vault and Veeva CRM strongly preferred\n\n* Expertise in solution architecture design, technical integration design and Vault platform best practices\n\n* Thorough understanding of system validation and change management\n\n* BA/BS in Information Technology, business, or science\n\n* Strong attention to detail\n\n* Strong analytical, consulting, and problem-solving skills\n\n* Understanding of drug development from Phase 2 to launch\n\n* Multitasking ability to work on several projects\n\n* Hands-on, roll-up-your-sleeves approach with high sense of urgency and drive for results\n\n* Ability to think outside of the box and challenge the status quo\n\n* Natural entrepreneurial spirit with unrelenting dedication to delivering results\n\n* Natural collaborator who enjoys working on a cross-functional team\n\n* Experience in Start-ups a plus.\n\n* Excellent communication and interpersonal skills.\n\n* Ability to work collaboratively with cross-functional teams.\n\n* Strong analytical and problem-solving skills.\n\n\n\n\nWork Environment:\n\n\n* Remote-based\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment\n\n* Domestic or international travel are required 10%\n\n\n\n\n \nCompensation is based on several factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity, sign-on bonuses, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave. The annual base salary for this position ranges from $170,000.00 - $185,000.00.\n \n\n \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Design, Travel and Senior jobs that are similar:\n\n
$70,000 — $110,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nNew York City, New York, United States
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
IMVT Corporation is hiring a Remote Senior Director Controller
\nThe Role:\n\nReporting to the VP Finance, this position is responsible for the controller group, producing accurate and timely financial statements, overseeing the close process and all other accounting responsibilities such as T&E, chart of accounts etc. The Controller will be the ultimate reviewer of the CRO and CMO accruals. This role requires strong managerial capabilities to drive process improvement, system implementations and employee development.\n\nKey Responsibilities: \n\n\n* Finalize accurate and timely monthly, quarterly and annual financial statements (balance sheet and statement of income) in accordance with GAAP. Design and manage the monthly close process to ensure timely and accurate financial statements.\n\n* Design, implement and maintain a system of internal controls to ensure safeguarding of Company assets and accurate financial statements.\n\n* Establish and enforce accounting policies and procedures and operational strategies including the review and implementation of process and system improvements.\n\n* Ultimate reviewer of CRO and CMO accruals, overseeing improvements to CRO and CMO accruals processes to support growth of the business.\n\n* Manage a team including multiple direct reports and a larger group of indirect reports ensuring appropriate allocation of responsibilities and sufficient back-up support.\n\n* Serving as principal contact with independent auditors.\n\n\n\n\nRequirements:\n\n\n* Bachelor’s degree in accounting and Certified Public Accountant.\n\n* 15+ years of experience - some in public accounting (big four), at least 10 years of experience in the biotech industry and at least 6 years of experience as a controller.\n\n\n\n\n\n* Experience with financial reporting at a publicly traded company.\n\n* Experience with CRO and CMO +accruals is a must.\n\n* Demonstrated ability to organize an efficient and effective monthly closing process.\n\n* Demonstrated ability to work in a dynamic and rapidly changing environment and the flexibility to handle multiple priorities simultaneously.\n\n* Team player, able to garner the respect of direct reports, peers, and superiors throughout the organization.\n\n* Strong communications and analytical skills.\n\n* Experience with NetSuite, Coupa, Expensify, Auxilius/Condor is preferred.\n\n\n\n\nWork Environment:\n\n\n* Remote-based\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment\n\n* Domestic or international travel are required (20%)\n\n\n\n\n \n\nCompensation is based on several factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity, sign-on bonuses, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave. The annual base salary for this position ranges from $250,000.00 - $265,000.00.\n\n \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Design, Travel, Accounting and Senior jobs that are similar:\n\n
$82,500 — $155,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Vedanta Biosciences is hiring a Remote Senior Systems Administrator
\nTitle: Senior Systems Administrator\n\nLocation: Cambridge, MA\n\nReports to: Head of IT Infrastructure & Operations\n\n \n\nAbout Vedanta Biosciences:\n\nVedanta Biosciences is a late-stage biopharmaceutical company developing medicines for the treatment of gastrointestinal diseases. The company’s lead assets include potential first-in-class oral therapies, VE303, a Phase 3-ready candidate for recurrent C. difficile infection, and VE202, in a Phase 2 trial for ulcerative colitis. Vedanta’s pipeline has been built using the company’s industry-leading product engine for the development of therapies based on defined consortia of bacteria grown from pure clonal cell banks. The product engine, supported by foundational IP, includes one of the largest libraries of bacteria isolated from the human microbiome, vast clinical datasets, proprietary capabilities in consortium design, and end-to-end CGMP manufacturing capabilities at commercial launch scale.\n\nThe Role:\n\nThe Senior Systems Administrator will support a Microsoft-centric computing environment consisting of Windows 2012/2016/2019/2022 servers for both corporate and GXP environments and associated Microsoft Cloud Technologies. This role will also assist in the support and administration of Azure, AWS, and Oracle fusion cloud. This position will report to the Head of IT Infrastructure & Operations. This role requires someone to be fully onsite, though some amount of remote work may be permissible in the future.\n\nHere’s What You’ll Do:\n\n\n* Administer, configure, and maintain Microsoft Azure services, ensuring the optimal performance and security of cloud resources.\n\n* Implement and manage M365 applications, including Exchange Online, SharePoint, and Teams.\n\n* Manage and maintain on-premises servers running Windows Server operating systems.\n\n* Administer storage solutions such as direct attached, SAN and NAS, ensuring data availability and integrity.\n\n* Design and implement solutions that seamlessly integrate on-premises infrastructure with Microsoft Cloud Technologies.\n\n* Implement and monitor security measures for both cloud and on-premises environments.\n\n* Conduct regular security assessments and audits and apply best practices to mitigate risks.\n\n* Manage user identities, roles, and access controls within both on-premises Active Directory and Azure Active Directory.\n\n* Implement and maintain multi-factor authentication and conditional access policies.\n\n* Utilize monitoring tools to proactively identify and resolve issues in both cloud and on-premises infrastructure.\n\n* Respond to incidents, conduct root cause analysis, and implement preventive measures.\n\n* Install, maintain, and upgrade server level hardware and software.\n\n* Conduct routine preventative maintenance on hardware and software systems.\n\n* Collaborate with cross-functional teams to understand business requirements and provide technical solutions.\n\n* Create and maintain comprehensive documentation related to systems architecture, configurations, and security policies.\n\n* Provide timely and effective support for servers and infrastructure during business hours as well as after-hours, as needed.\n\n* Assume additional responsibilities as requested.\n\n\n\n\nRequirements:\n\n\n* 5+ years of experience in a Microsoft IT environment, biotech industry and/or GMP experience preferred.\n\n* BS preferred, preferably in a relevant field such as Computer Science or Information Technology. Microsoft or AWS certifications a plus.\n\n* Experience with Microsoft M365 Suite, Azure, Intune, MFA, Microsoft System Center, Microsoft Hyper-V, Microsoft Exchange Online, Microsoft Defender Suite, Dell Servers, EqualLogic, and Synology SAN’s as well as Veeam backup solutions.\n\n* Scripting and automation skills using PowerShell or other relevant tools.\n\n* Technical experience working with Windows server computer systems.\n\n* Strong understanding of cybersecurity principles and best practices.\n\n* Possess excellent verbal and written communication skills with an ability to influence others.\n\n* Ability to function in a fast-paced, service-oriented environment. Ability to prioritize multiple projects daily and adjust to shifting priorities.\n\n* Strong planning, project management, and organizational skills.\n\n* Strong sense of urgency and a high-energy level.\n\n* Familiarity with analyzing, working with, and presenting data.\n\n* Possess a “hands-on” tactical approach.\n\n* Creative and proactive approach to problem solving.\n\n* Strong analytical abilities, resourcefulness, and attention to detail.\n\n* Ability to work independently and as part of a team with a proactive and positive style that fosters collaborative working relationships. Outstanding sense of customer service.\n\n* Deep personal commitment to integrity, excellent judgment, and the highest standards of ethics.\n\n* Must display the highest level of diplomacy, tact, and discretion, with comfort in handling and maintaining confidential information.\n\n* Ability to quickly get up to speed and master new applications and software is critical.\n\n* Ability to provide on-call and off-hours support as needed.\n\n\n \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Cloud, Microsoft and Senior jobs that are similar:\n\n
$60,000 — $90,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nCambridge, Massachusetts, United States
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Dyne Therapeutics is hiring a Remote Chief Information Officer
\nRole Summary:\n\nThe Chief Information Officer (CIO) is a key role responsible for defining and evolving Dyne’s technology and digital strategy, vision, and roadmap in line with the business strategy, to drive innovation, efficiency, and competitive advantage to enable organizational success, growth, and commercial readiness. This role requires an understanding of and deep experience with the full drug development lifecycle from research and development through commercialization. This role requires a strategic leader experienced with preparing an organization’s integrated technology infrastructure for commercialization and taking products to market. This leader is responsible for developing an IT roadmap, identifying, and executing on initiatives that drive tangible business outcomes that accelerate drug development timelines, ensure data integrity, compliance, and operational effectiveness.\n\nThis is a full-time position based in Waltham, MA without the possibility of being remote.\n\nPrimary Responsibilities Include:\n\n\n* Collaborate closely with cross-functional leaders to develop comprehensive strategies that drive business success and operational excellence, optimizing product development, and establishing commercialization processes\n\n* Align technology initiatives with the overarching business objectives, guaranteeing that Dyne’s corporate technology supports its operations and objectives including digital transformation, cybersecurity, and commercial readiness\n\n* Provide the strategies and technology solutions to enable the launch of products globally\n\n* Implement commercial, manufacturing and supply chain, and ERP business processes and systems\n\n* Lead and grow a strong global IT team, fostering a culture of innovation, collaboration, and continuous improvement, providing mentorship and professional development opportunities to team members to enable efficient and scalable operations, with particular focus to building of commercial capabilities\n\n* Define the operating model to enhance IT's capabilities\n\n* Continue to scale robust governance protocols to ensure product/platform compliance, policy development, and management of risks\n\n* Continue to scale a robust IT Security organization to protect Dyne’s assets and ensure global regulatory and privacy compliance\n\n* Evolve the cross-functional technology governance body to ensure alignment of technology and business goals\n\n* Develop an enterprise AI Strategy and prioritization framework and an enterprise data management strategy including retention and governance standards\n\n* Evolve and right size the ITGC, IT SOX, and SEC Cybersecurity controls\n\n* Responsible for maintaining a stable, qualified, and highly available computing infrastructure and implementation of validated computer systems.\n\n* Partner with Finance to develop and lead the IT portfolio budget, ensuring sufficient resources are allocated for technology investments, returns are realized, and future investments are balanced across business needs, while providing a stable and efficient support operating model\n\n* Direct the development of the IT sourcing strategy and provide executive oversight for strategic vendor and partner relationship management\n\n* Provide strategic direction for cybersecurity program using a risk-based approach, direct internal and external services to execute on a proactive strategy, and ensure program agility to adapt to and evolving threat landscape\n\n* Drive commercial readiness in IT processes and related business processes to ensure business achieves timely benefits from investments\n\n* Partner with Quality Assurance and business system owners across the organization to ensure GxP computerized systems are optimized for business needs, operating effectively, efficiently, and in compliance US GxP regulations and EU guidelines\n\n* Foster strong relationship[s, including proactive planning and cultivation of external partnerships\n\n\n\n\nEducation and Skills Requirements:\n\n\n* Bachelor's degree or equivalent experience in technology or related field\n\n* Twenty plus (20+) years related experience, including 5+ years as a strategic IT executive within a biotech\n\n* Commercial biotech build experience across commercial, manufacturing and supply chain, and ERP business systems in a strategic, head of IT or CIO role\n\n* Demonstrated initiative and ability to navigate ambiguity, and the ability to grow as the company scales in size\n\n* Experience building a commercial ready IT infrastructure, processes, and controls\n\n* Working expertise of HIPAA, Sarbanes-Oxley, FDA, GDPR compliance\n\n* Expert knowledge of regulatory compliance including SEC, SOX, CFR Pt.11, EU Annex 11, cGxP, HIPAA, PDMA, GDPR and support to commercialization\n\n* Ability to translate business needs into a strategic IT roadmap, communicate that roadmap at all levels of the organization, and effectively implement that roadmap into operational success for the organization\n\n* Experience supporting all levels, partnering with senior leaders to identify needs and implement scalable capabilities to support their functional goals\n\n* Expert knowledge of vendor management and technology business management processes and methodologies\n\n* Extensive experience with software development life cycle in regulated environment\n\n* Excellent communication skills (verbal, written, presentation) and ability to communicate well with stakeholders at all levels\n\n* Ability to lead both independently and in a team-oriented, collaborative environment\n\n* Ability to conform to shifting priorities, demands and timelines through analytical, and problem-solving capabilities\n\n* Effective influencing and negotiating skills in an environment with cross functional teams, contractors, resources, and third-party vendors\n\n\n\n\n \n\n \n\n \n\n#LI-Onsite \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Finance and Senior jobs that are similar:\n\n
$70,000 — $130,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nWaltham, Massachusetts, United States
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Erasca is hiring a Remote Sr Manager Assoc Director Regulatory Affairs
\nPosition Summary: \n\nReporting to the SVP, Regulatory Affairs, the Senior Manager or Associate Director of Regulatory Affairs will lead and participate in regulatory activities associated with IND/CTA development and maintenance for support of new and ongoing clinical trials. This role requires an independent, self-directed, and highly motivated clinical regulatory professional.\n\nPosition Responsibilities:\n\n\n* Represent regulatory on study and program teams throughout study conduct and product development.\n\n* Prepare and/or review regulatory documents required for product development (e.g. New IND/CTAs, DSUR, health authority briefing document, iPSP/PIP, NDA/MAA)\n\n* Serve as the primary contact with the FDA, and lead development of global regulatory submissions, including requests from regulatory authorities relating to clinical trials, and responses to health authority requests for information, as required.\n\n* Provide oversight of regulatory submissions to assure technical accuracy, compliance, and completeness.\n\n* Provide regulatory support for company compliance initiatives, including SOP development, Veeva and documentation initiatives, etc.\n\n* Review relevant clinical documents (protocol, informed consent form, investigator’s brochure, and site documentation, and required regulatory forms) for regulatory compliance.\n\n* Keep current on US and OUS regulations that apply to company products and processes.\n\n* May support other global submission activities as appropriate, independently or in collaboration with the Regulatory Affairs Head or Regulatory Affairs program lead\n\n* Perform all duties in keeping with the Company’s core values, policies, and all applicable regulations.\n\n\n\n\nPosition Requirements:\n\n\n* Undergraduate degree required; advanced degree preferred.\n\n* 4+ years of experience in pharmaceutical or biotech regulatory affairs including clinical regulatory affairs for oncology products.\n\n* Ability to translate regulatory requirements into practical workable plans.\n\n* Diverse experience with regulatory activities including creation of systems and processes to support efficient and high quality submission of documents to regulatory bodies.\n\n* Strong organizational skills that reflect the ability to perform and prioritize multiple tasks with excellent attention to detail.\n\n* Ability to build strong relationships with co-workers of various backgrounds and expertise.\n\n* Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment.\n\n* Effective interpersonal and communication skills; must be a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex technical problems.\n\n* Strong learning orientation, curiosity, and passion for science and patients.\n\n\n\n\n \n\nThe anticipated salary range for this position is $190,000 to $200,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etcetera. In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price. \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Senior and Senior jobs that are similar:\n\n
$60,000 — $110,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nSan Diego, California, United States
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
IMVT Corporation is hiring a Remote Associate Director Biostatistics
\nOrganizational Overview:\n\nImmunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.\n\nThe Role:\n\nReporting to the Senior Director, Biostatistics, this position is responsible for collaborating with both internal and external stakeholders to deliver the tactical execution of our Biostatistics strategy. The individual in this position will have the unique opportunity to participate in the rapid growth of a biotech startup.\n\nKey Responsibilities: \n\n\n* Provide statistical inputs into protocol and clinical study report development, statistical analysis plans, interpretation of statistical analysis results, randomization plans.\n\n* Provide oversight and review of statistical documents for multiple clinical trials, including TLF shells, eCRFs, specifications of variable derivations, and all deliverables from outside vendors or internal programmers.\n\n* Develop effective collaborations with others within clinical teams and partner lines (such as Statistical Programming, Data Management, Medical, Clinical Operations, and Regulatory).\n\n* Ensure that all study level statistical activities are conducted in compliance with relevant regulatory requirements and Immunovant standards.\n\n* Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports.\n\n* Oversight statistics and programming vendors.\n\n* Open to opportunities to utilize innovative statistical methodology to streamline the clinical development process and facilitate optimal decision-making.\n\n\n\n\nRequirements:\n\n\n* PhD or MS in Statistic, Biostatistics, Mathematics, or related field\n\n* 5+ years (7+ years for MS) of experience in biotechnology, pharmaceutical or health related area\n\n* Knowledge of relevant FDA, EU, ICH guidelines and regulations\n\n* Understanding of drug development\n\n* Demonstrated ability to collaborate with diverse sets of stakeholders\n\n* Strong written and oral communication skills with attention to detail\n\n* Desire to work in a fast-paced, innovative environment\n\n* Natural collaborator who enjoys working on a cross-functional team\n\n\n\n\nWork Environment:\n\n\n* Remote-based; access to Immunovant’s NYC and North Carolina offices available\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment \n\n* Domestic or international travel may be required (~10%)\n\n\n \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Travel and Senior jobs that are similar:\n\n
$100,000 — $155,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nNew York City, New York, United States
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
IMVT Corporation is hiring a Remote Senior Director Associate General Counsel
\n \nCompany Description:\n\nImmunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As a leader in FcRn inhibitor technology, we are boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. Our investigational compounds, batoclimab and IMVT-1402, are novel, fully human, monoclonal antibodies targeting the neonatal Fc receptor (FcRn). Both are optimized as a subcutaneous injection with potential flexibility in dosing and approach and are designed to reduce immunoglobin G (IgG) antibodies that cause inflammation and disease.\n\n \n\nDue to our growth, we are seeking an Associate General Counsel to join the Immunovant legal department, occupying a position of significant responsibility and reporting directly to Immunovant’s Chief Legal Officer. This individual will work cross-functionally and throughout the organization to provide a broad array of legal and compliance support. The attorney will support Immunovant’s development programs and its multiple clinical trials, SEC filings, and provide counsel and guidance on privacy, business development/alliance management and strategic transactions. High-quality performance in this role will contribute meaningfully to Immunovant’s overall success.\n\n \nKey Responsibilities:\n\n\n* Provide high quality legal advice and serve as a trusted strategic partner to a variety of internal teams\n\n* Coordinate transactional workflows to ensure consistent and efficient delivery of legal support\n\n* Draft and negotiate a broad range of agreements with a particular emphasis on clinical development agreements and related matters\n\n* Serve as a generalist on complex legal and compliance matters for Immunovant, adding legal and business value across all functional areas\n\n* Maintain frequent contact with all functions within the company while managing requests and prioritizing projects\n\n* Develop and present materials on relevant legal and business issues\n\n* Support business development, securities offerings, and other transactions\n\n\n\n\n \nRequirements:\n\n\n* Juris Doctor degree from an ABA-accredited law school and admission to at least one state bar\n\n* 10+ years of relevant experience including biotech/biopharma/pharma experience in an in-house setting and 15+ years of overall legal experience\n\n* Significant transactional experience and exemplary drafting and negotiating skills on a wide range of agreements\n\n* Excellent judgement and ability to asses risks and benefits and convey them in a clear and concise manner\n\n* Strong work ethic and ability to work independently, yet collaboratively, at all levels of the organization with minimal supervision\n\n* Self-motivated, self-starter, and independent\n\n* Excellent productivity, organizational, and time management abilities\n\n* Demonstrated ability to quickly grasp scientific and technical concepts\n\n* Agility and flexibility to handle multiple tasks in a fast-paced, dynamic, biotech environment\n\n* Effectively handle all job office equipment and software (including computer, Microsoft Office, SharePoint, and Slack)\n\n* Outstanding attention to detail and ability to react and respond quickly and effectively\n\n* Ability to exercise initiative and sound judgment and identify opportunities for improvement\n\n* Excellent written and verbal communication skills\n\n* Strong interpersonal skills\n\n* Creative problem solver and ability to think “out of the box”\n\n\n\n\n \nWork Environment:\n\n\n* The position is remote (work from home)\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment\n\n* Travel as required (<5%)\n\n\n\n\n \n\nCompensation is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Equity, sign-on bonuses, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k and other benefits, including unlimited paid time off and parental leave. The annual base salary for this position ranges from $280,000.00 - $300,000.00.\n\n \n\n \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to React, Microsoft, Senior and Legal jobs that are similar:\n\n
$60,000 — $110,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Tempus is hiring a Remote Manager of Business Development Studies
\nPassionate about precision medicine and advancing the healthcare industry?\n\nRecent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus has developed novel technology that generates, collects, structures, and analyzes vast amounts of data; and, merged with the power of AI, we can advance precision medicine for today and facilitate discovery, development, and delivery of optimal therapeutics for tomorrow. \n\nWe are looking for a Manager of Business Development to join our Clinical Studies organization. This individual will be a key member of our commercial team, helping to drive strategy and business development efforts for our group. This role will focus on powering the top of the funnel by engaging and qualifying accounts to help grow and expand our business while driving revenue. Day-to-day responsibilities will include generating awareness, qualifying leads, and ultimately contracting new projects with pharma and biotechnology clients to support them in advancing their research, clinical, and commercial programs. \n\nResponsibilities\n\n\n* Expand Tempus’ footprint into pharma and biotech, interfacing with internal and external teams to identify potential customers, drive awareness, qualify opportunities, and accelerate the growth of the Clinical Studies business\n\n* Grow the Clinical Studies funnel across our offerings and craft strong proposals in collaboration with our scientific, technical, and operational experts to generate new business\n\n* Support the design and development of clinical studies into the global account strategy of top-tier targets in coordination with Key Account Directors \n\n* Sell new projects with customers in a quota driven environment\n\n* Own negotiating, securing and managing contract pull-through \n\n* Drive strategic thinking and interface with internal Tempus teams, including marketing, commercial strategy, operations, and others to develop novel study offerings that meet our customer’s needs\n\n\n\n\nEducation and Experience\n\n\n* Bachelor's degree in an analytical or healthcare related field, PhD/MD/MBA strongly preferred\n\n* Minimum 3-7 years in a fast-paced sales environment with focus in oncology, clinical studies, drug research & development or real world data/evidence\n\n* Proven track record of establishing and building customer relationships \n\n\n\n\nQualifications\n\n\n* History of meeting and exceeding sales targets and quotas\n\n* Demonstrated ability to partner with senior biopharma and diagnostic partners to clearly understand their needs and deliver thoughtful solutions\n\n* Hands on experience developing novel clinical study and clinical research offerings to serve pharma and biotech customers\n\n* Experience with projects involving multidisciplinary teams and stakeholders\n\n* Thrives in a high growth, rapidly evolving cross-functional team environment\n\n* Excellent written and verbal communication skills\n\n* Ability to clearly present and demonstrate Tempus capabilities to customers\n\n\n\n\n#LI-NK1 \n#LI-Remote\n\n \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Design, Senior and Sales jobs that are similar:\n\n
$50,000 — $100,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nChicago, Illinois, United States
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Dianthus Therapeutics is hiring a Remote Senior Manager Data Sciences
\nAbout Us\nDianthus Therapeutics is a publicly traded, clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who are leading the development of next-generation antibody complement therapeutics, aiming to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases. To learn more, please visit www.dianthustx.com and follow us on LinkedIn.\n\n\nAbout the Role\n\nThis role is responsible for overseeing data-specific timelines and deliverables (both internal and external) from start-up through close out of various clinical trials. This includes coordination and timing for data transfers, internal and external data reviews, data deliverables for interim/final analyses, DSMB meetings and any other data-related deliverables.\n\nYou will report to the Director, Data Sciences and will independently support all active programs to ensure complete, accurate, high quality and regulatory compliant data in support of internal or external stakeholders, study reports, publications and regulatory submissions. This position requires both the knowledge and experience to work within established clinical trial paradigms while embracing new approaches to facilitate data aggregation and analysis in the advancement of patient care.\n\nThis is a unique opportunity to be part of a team driven by continuous innovation with very high scientific integrity and who hold our core principles at the center, with the goal to elevate the care of our patients’ lives. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.\n\nKey Responsibilities\n\n\n* Cultivate and manage relationships with DM partners (eg, CROs and other vendors) and cross functional team members to ensure data are reviewed and delivered with high quality, are on-time and within scope\n\n* Accountable for ensuring timeliness of data deliverables are met and align with company goals\n\n* Monitor and track data-related timelines and deliverables and serve as central point of communication for other cross-functional team members\n\n* Document data workflows for assigned studies, ensuring transfers occur based on study-specific needs\n\n* Support the development of standard operating procedures (SOPs) and processes with a focus on continuous improvement and increased efficiency\n\n* Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing relevant data processes, documents, outputs and filing documentation in the trial master file (TMF).\n\n* Other related duties as may be determined or assigned.\n\n\n\n\nExperience\n\n\n* University degree required within a relevant discipline. Life Sciences experience is a plus.\n\n* Skilled in management of timelines and coordination with internal and resources to efficiently reach deliverables\n\n* Comprehensive understanding of DM related systems and technologies\n\n* Comprehensive knowledge of drug development and clinical research processes, GCP guidelines and regulations related to clinical data management\n\n* Self-motivated and able to work autonomously, as well as a member of a high-functioning and collaborative team.\n\n* Highly organized and detail-oriented.\n\n* Strong verbal and written communication skills with an ability to build relationships internally and externally.\n\n* Highest levels of professionalism, confidence, personal values and ethical standards.\n\n\n\n \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Senior and Senior jobs that are similar:\n\n
$40,000 — $80,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nWaltham, Massachusetts, United States
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Lightship is hiring a Remote Senior Client Partner Strategic Accounts
\n\n\n\n\nOverview\n\nLightship is a clinical trials service provider leading in increasing access and choice in taking part in research to improve equity for all. We design and conduct studies in partnership with biopharmaceutical companies to accelerate bringing new therapies to market. Our approach is to engage people where they are and support them across their journey in a clinical trial, from first contact to study completion. We work to make it easy, convenient, and safe for people to take part by offering visits in clinic, at home, using our mobile research units, and digital health tools. By transforming the way, we conduct clinical research, we can decrease study timelines and reduce dropouts to accelerate development of better therapies.\n\nThe Senior Client Partner, Strategic Accounts contributes to Lightship’s ongoing growth by supporting the design and implementation of solutions that increase patient access and choice in clinical trials. This individual is highly motivated and has an extensive understanding of clinical research from the perspective of clients, partners, and Lightship clinical teams. Additionally, the Senior Client Partner, Strategic Accounts is well-versed in technologies and systems used in clinical research. This individual leads the development of Lightship design concepts, study assessments, pricing development, and continued client engagement once a program or study has launched to ensure, measure, and manage project success. The individual, as required by the business, leads strategic client accounts and relationships to identify, develop and grow business with pharmaceutical and biotech companies.\n\nGiven Lightship’s distributed model and the remote nature of this position, the Senior Client Partner, Strategic Accounts must possess a willingness and desire to work independently without significant oversight. Lightship expects each individual to anchor their availability in the standard operating hours for their geographic location, however, true to our values of inclusion and flexibility, this role, along with all others at Lightship, may be asked to flex work hours to accommodate US West Coast, US East Coast, and UK-based time zones, based on business and/or patient needs. In practice, this may translate to days that have a slightly earlier start or evenings that have a slightly later end. Culturally, we aim to balance the ability to operate across time zones with respect for each individual's daily life. Additionally, this position will require significant travel for client visits and key meetings.\n\nSenior Client Partner, Strategic Accounts is responsible for:\n\n\n* Driving strategic client relationships from both a business and delivery perspective. Forging new relationships and developing existing relationships with Pharmaceutical, Biotechnology and CROs\n\n* Leading efforts to design, assess, price, and contract Lightship projects, while working cross-functionally with internal teams and externally with sponsors, partners, and vendors, ensuring seamless communication and collaboration among all parties\n\n* Carrying out market research and analysis to inform design concepts at program and study levels\n\n* Developing, leading, and improving client interactions, engagement, and presentations\n\n* Leading consultations with client study teams to result in contracted Lightship projects which meet client expectations and operational commitment on deliverables\n\n* Build and maintain a business development funnel of opportunities through a solid understanding of strategy, industry and competitive landscape.\n\n* Supporting efforts to complete program assessments and capability building programs with clients\n\n* Continuously developing and evaluating opportunities to improve, enhance, or expand Lightship services, offerings, and client engagement\n\n* Engaging clients once a study has launched to ensure customer success, identify opportunities for process improvement, contract amendments, and communicate feedback effectively to internal stakeholders\n\n* Partnering with clinical operations to ensure that design of each program or study opportunity includes development of study-level metrics, clinical trial processes, guidelines, and requirements which can be followed throughout the trial lifecycle\n\n* Partnering with proposals and budget team to develop proposal responses and budgets\n\n* Lead and/or participate in bid defense meetings with clients\n\n* Supporting Lightship’s various business units in assessing potential success factors and risks, including risk management plans for proposed trials\n\n* Assisting in development of clinical budget, expense review strategies, and other tools/processes for commercial team\n\n* Participating in development and review of Lightship’s Standard Operating Procedures (SOPs), guidelines, and training materials; assessing training program needs for various Lightship trials\n\n* Other duties as assigned\n\n\n\n\nSenior Client Partner, Strategic Accounts has:\n\n\n* Required knowledge, skills, and abilities:\n\n\n* Ability to successfully manage people and projects\n\n* Ability to build and lead collaborative research teams, with team members from various Lightship departments and outside organizations, including sponsors, partners, and vendors\n\n* Ability to adapt to a fast-paced start-up environment\n\n* Ability to critically review and assess protocols identifying opportunities to innovate\n\n* Ability to collaborate cross functionally with ease\n\n* Ability to influence others and drive clarity in ambiguity\n\n* Expertise in clinical operations and advanced knowledge of clinical research\n\n* Critical thinking and problem-solving abilities\n\n* Strong verbal and written communication skills; strong presentation skills\n\n* Strong negotiation skills\n\n\n\n\n\n\n\n* Education and experience\n\n\n* 10+ years of clinical operations, project management, client relationship and alliance management experience and / or clinical research background\n\n* 7+ years of management experience\n\n* Experience in Phases I-IV of clinical trials\n\n* Management experience in a clinical field\n\n* Bachelor’s Degree, required; advanced degree in healthcare-related field or MBA, preferred\n\n* Requisite combination of education, training, and experience\n\n\n\n\n\n\n\n\n\n\nWe would like to offer you: \n\n\n* An opportunity to help re-envision how clinical research is executed with inclusivity, increased diversity and accessible at the core\n\n* The chance to work with a patient-centered, clinically-oriented, collaborative team to support in the delivery of enterprise grade virtual-first clinical research solutions at scale\n\n* An unmatched opportunity to grow as part of an established startup with industry veterans, high-caliber investors, and a massive market opportunity\n\n* Great compensation\n\n\n\n\nGenerous benefits package, including:\n\n\n* Top notch healthcare (medical, dental, and vision) for you and your family.\n\n* Unlimited Paid Time Off (PTO), plus paid holidays and bereavement to help support work life balance.\n\n* A 100% 401(k) company match for up to 4% of eligible contributions with an immediate vesting.\n\n* A home office stipend to set yourself up for success in our distributed working environment\n\n* Company provided laptop, your choice of a PC or a Mac\n\n* Monthly stipend for internet and phone expenses\n\n* Generous paid parental leave\n\n* Short & long-term disability\n\n* Life insurance and More!\n\n\n\n\nThe base salary range for this role is dependent on education, skills, and experience. To determine our compensation, we use a market-based approach that is geographically neutral. We believe that this demonstrates our company value of ‘believing in people’ – valuing the outputs and performance of each team member.\n\nPlease note: For the safety of our patients and each other, all positions at Lightship that require travel, in-person participation, or are patient-facing, do require vaccination against COVID-19.\n\nOur commitment to diversity & inclusion:\n\nLightship is an equal opportunity employer and promotes a diverse and inclusive workplace. Lightship considers all applicants without regard to race, color, religion, creed, national origin, age, sex, marital status, ancestry, disability, veteran status, gender identity, genetic information, sexual orientation, or any other status protected by applicable law. EEO is the Law\n\nLightship is an E-Verify employer. Find out more here: Right to Work Poster E-Verify Participation Poster\n\n#jobs #careers #nowhiring #hiringnow #LI-remote\n\n \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Design, Mobile and Senior jobs that are similar:\n\n
$50,000 — $110,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nLondon, England, United Kingdom
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Cerevel Therapeutics is hiring a Remote Director Clinical Trials Transparency and Disclosure
\nCompany Overview\n\n\nCerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity. Our portfolio of pre-commercial neuroscience assets targets a broad range of central nervous system (CNS) disorders, including schizophrenia, epilepsy, Parkinson’s disease and substance use disorder. \n \nHeadquartered in the Greater Boston area, we are bold thinkers, deep experts, resilient pathfinders, and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on people’s lives.\n \nCerevel aspires to develop and nurture a culture characterized by trust, respect, courage, curiosity, and compassion, with a relentless focus on mission and results. Our patient-centricity guides our purpose, how we treat each other and what we work on every day. The successful candidate will bring their own unique thinking and approach to Cerevel while sharing our core values and convictions.\n\n\nRole Summary:\nThe Director of Clinical Trials Transparency and Disclosure is responsible for leading and managing Global Clinical Trial Disclosure and Data Transparency activities per applicable laws, regulations, and policies. This role will serve as a subject matter expert and primary point of contact for Cerevel’s transparency and disclosure activities (eg, clinical trial results postings, document redactions, and layperson results summaries). The Director will partner with and lead interactions with senior management and team members in relevant functional areas and manage staff and/or vendors who are directly involved in activities related to disclosure and transparency. The successful candidate must be flexible, detailed oriented, self-directed and manage workload to meet submission timelines across all company programs.\n\n\n\nKey Responsibilities\n* Lead Global Clinical Trials Transparency Workstream and provide vendor oversight; potentially build and manage a Clinical Trial Transparency and Disclosure team\n* Establish strategic plans and objectives for Cerevel’s global clinical trials transparency and disclosure capabilities\n* Lead the development of Cerevel’s overall global clinical trials transparency and disclosures policy with key stakeholders, updating the policy as necessary\n* Manage the preparation of plain language (layperson) summaries and redaction of clinical documents in accordance with EMA Policy 0070, EU Clinical Trial Regulation, Health Canada Public Release of Clinical Information (PRCI), and other global regulations\n* Educate and provide company-wide awareness of transparency/disclosure regulations and industry trends\n* Coordinate efforts of cross-functional teams to produce high-quality, scientifically accurate documents & postings (eg, plain language [layperson] summaries, interim and/or final results postings, and redaction documents); acting as liaison between the vendor and Cerevel teams\n* Work on multiple projects/across programs, coordinating work plans that align with corporate timelines and strategic plans\n* Lead teams in the preparation and maintenance of CCI and PPD rules across programs, ensuring consistency of publicly disclosed information across countries, websites, databases, and documents\n* Lead initiatives (including trainings and workshops) and develop/update SOPs, work instructions, and user guides, as needed\n* Ensure lean writing practices for regulatory documents such as clinical trial protocols, Investigator’s Brochures, and Clinical Study Reports to minimize CCI and PPD\n* Act as a subject matter expert during regulatory inspections\n\n\n\nRequired Qualifications\n* Minimum of 8 years experience in the biotech or pharma industry; including a minimum of 5 years in transparency and disclosure. Advanced degree/academic research or other transferrable skills may be considered in lieu of industry experience.\n* Experience writing plain language (layperson) summaries, results postings, and redactions and understanding of Good Lay Summary Practice (CTEG working Group)\n* Expertise with postings on clinicaltrials.gov and with EU CTR 536/2014 regulations\n* Deep understanding of US and EU requirements for global transparency and clinical trial disclosure as well as other related policies (ICMJE, PhRMA/EFPIA principles for responsible data sharing, etc.)\n* Experience working with CTIS preferred\n* Understands the clinical drug development process, including clinical trial design, operations and results analysis\n* Strong leadership, planning, and project management skills, along with initiative and ability to be productive independently and with minimal administrative support\n* Ability to evaluate and recommend process improvement and suggest/implement best practices\n* Outstanding oral and written communication skills\n* Strong analytical and problem-solving skills; ability to organize/track complex information & prioritize\n* Flexible; adapts work style to meet organization needs\n* Proficient with Microsoft Office products such as (Outlook, Word, Excel, PowerPoint, SharePoint, and Teams), Smart Sheet, Please Review, Veeva Vault, and Adobe Suite\n\n\n\nDesired Qualifications\n* Recent neuroscience experience (within 2 years)\n* Experience contributing to outsourcing strategies and vendor selection, including resourcing/budgeting forecasts for assigned projects\n* Prior experience working in Clinical Development, Clinical Operations, or Medical Writing\n* 2+ years’ managing direct reports\n\n\n\nEducation\n* Academic degree (BA/BS at minimum) in a relevant scientific or healthcare discipline, advanced degree (eg PhD) in scientific or healthcare field preferred\n\n\n\n\n\nCerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law. \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Microsoft and Senior jobs that are similar:\n\n
$50,000 — $85,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nBoston, MA (Remote)
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Alpine Immune Sciences is hiring a Remote Director Clinical Trial Liaisons
\nAlpine Immune Sciences is a leading clinical-stage biopharmaceutical company dedicated to discovering and developing innovative, protein-based immunotherapies for autoimmune and inflammatory diseases. Exciting challenges lie ahead—guided by our core values, we’ll meet these challenges. Join us!\n\n\n\n\nThe Director, Clinical Trial Liaisons (CTL) is a critical position within Alpine Immune Sciences (ALPN) Clinical Operations team and will be responsible for developing and providing non-promotional clinical information and study support across ALPN’s clinical development portfolio. Poised and articulate, the CTL Director is a listener and educator, problem solver, and a gifted cultivator of new and existing relationships. This position reports to the Head of Clinical Operations.\n \nDuties and responsibilities\n \n• Will direct field-based staff to forge, cultivate, and maintain relationships with a range of key clinical site/study personnel (Investigators, Study Coordinators, Pharmacists, and Clinical Research Associates, etc.) to build a well-informed and motivated clinical site base for ALPN’s clinical development programs. \n• Develop a strong understanding of clinical site practices to curate and deliver clinical site engagement strategies \n • Gathers and shares “Best Practices” and tactics for rapid patient enrollment among trial sites. \n • Gathers data and information on leading indicators of site challenges/successes and feeds back to the study management team and other functional stakeholders to develop pragmatic solutions to address challenges to enable successful execution of studies.\n• Partners with sites to understand barriers to clinical trial participation and develops and implements effective local and regional subject recruitment strategies, suggest local outreach options, facilitate escalation of site questions/concerns, and develop recruitment/retention initiatives. \n• Establish process to ensure site staff requests are managed efficiently and effectively, positioning ALPN’s clinical studies as a high priority within investigational site operations.\n• Collaborates with ALPN Clinical Operations, Clinical Development, and external stakeholders to support study performance and progress.\n• Frequent and varied site and study leadership engagement through presentations at site initiation, office visits, investigator meetings, and/or advisory boards to enhance current and future clinical trial awareness.\n• Facilitates identification of clinical trial site and community educational needs for ALPN clinical trials.\n• Participates in ALPN community outreach and engagement activities for ALPN clinical trials.\n• Maintains business and clinical knowledge of the treatment landscape including current treatment strategies, current and pending competitors, and new therapeutic developments.\n \nQualifications\n \nTo perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities, and prior experience required.\n \n• At least 5 years clinical trials leadership experience\n• Previous experience in a CTL, MSL, or similar site-facing role preferred\n• Strong communication, interpersonal, and relationship management skills\n• Ability to travel domestically and internationally up to 70%; including travel to ALPN at least 6 times/year\n• Working knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring\n• High attention to detail\n• Ability to set priorities and juggle multiple demands\n• Ability to think critically and be a proactive problem-solver\n• Ability to work independently while exercising initiative, flexibility, and sound judgment\n• Comfortable working with various levels of the company including senior level management\n• Demonstrated proficiency in Microsoft Word, PowerPoint, and Excel\n• Ability to operate in alignment with ALPN’s values\n\n\n#LI-Remote\n \n\n\n\n\n\nAt Alpine we engage equitable workplace strategies to ensure fair compensation. Actual compensation is dependent upon current market data, experience, and pay parity within our organization. This position is a Director level position, with a compensation range of $200,000 - $230,000. Note that there is a strong preference for candidates to be located in one of the following five states: CA, MA, NC, OR, or WA. We take care of our employees with a competitive benefits package that includes stock options, annual bonus, premium medical, dental, and vision coverage for employees and their dependents, as well as life and disability benefits, FSA, and 401(k) plans. We believe quality time outside the office is vital to our employees’ satisfaction at work, so our flexible PTO plan of 160 hours, generous holiday time (generally 12 days), and parental benefits encourages team members to take time off so they can come back refreshed. Alpine team members enjoy competitive salaries and equity participation (stock options).\n\n\nAlpinists share a passion for meaningful work and are committed to solving the most complex problems in immunology to create new therapies for patients. We believe in innovative thinking, collaboration, flexibility, bias for action, and healthy debate. To foster our team of outstanding scientists and business professionals, we provide a premier work environment with a state-of-the-art lab and office spaces with truly inspiring views, and an open design to facilitate teamwork.\n\n\nOur treasured culture has been shaped by our diverse team who truly enjoys working and playing together. We nurture Alpine’s culture in many ways, including all-company social events and happy hours, lunch-and-learn and education opportunities, interest groups like book club and movie nights, peer-to-peer recognition programs, a robust wellness program to help support physical, mental, and emotional health, and more.\n\n\nAlpine is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Alpine is also committed to compliance with all fair employment practices regarding citizenship and immigration status.\n\n\nOur office and lab are located in the blossoming biotech neighborhood of Eastlake in Seattle. Alpinists enjoy the flexibility to work onsite, remotely, or a hybrid schedule, with evolving options as we prioritize keeping Alpinists safe and healthy. Onsite employees enjoy an open-office layout with comfortable huddle rooms and Zoom Room-enabled conference rooms, a spacious breakroom and kitchen with a coffee bar and snacks, and rooftop access to enjoy gorgeous views of Lake Union and Gas Works Park.\n\n\nExciting challenges lie ahead—guided by our core values, we’ll meet these challenges. Join us!\n \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Design, Education, Microsoft and Senior jobs that are similar:\n\n
$45,000 — $85,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nSeattle, WA or Remote
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Prilenia is hiring a Remote Senior Director Commercial Supply Chain and Manufacturing
\nAbout Prilenia \nPrilenia Therapeutics, a clinical-stage biotech company focused on the urgent mission of developing novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, is looking for a Senior Director, Commercial Supply Chain and Manufacturing to join its team in the East Coast of the United States or Europe.\nWe are a flexible, fast-moving team that is quickly advancing a potential therapy poised to have major impact on the lives of patients and their families. Our lead product candidate, pridopidine, is a first-in-class small molecule, holding Orphan Drug Designation in both Huntington’s disease (HD) and Amyotrophic lateral Sclerosis Amyotrophic (ALS) in the U.S. and EU, as well as Fast Track designation from the FDA for the treatment of HD. Prilenia is working on preparing for a potential regulatory filing for HD and for starting a global phase 3 in ALS with pridopidine.\nPridopidine has the potential to be the first treatment to address HD disease clinical progression. Prilenia also believes pridopidine’s novel mechanism of action as a Sigma-1 receptor agonist gives it potential in numerous other neurological diseases. \n \nAbout the role\nWe seek a forward-thinking supply chain hands-on leader to join our team as Senior Director, Commercial Supply Chain and Manufacturing. This position will establish end-to-end global commercial supply chain strategy and serve as an internal SME for matters related to commercial manufacturing, demand planning and global logistics including packaging, shipping, and serialization validation. The ideal candidate will bring in-depth expertise in clinical and commercial supply chain management, launch readiness, DP manufacturing, packaging and labeling, serialization, supply planning, supplier (CDMO) relationship management, contract negotiation, sales and operations planning (S&OP), inventory management, third-party logistics (3PL), process improvement, and strategic planning. A flexible and innovative problem solver who formulates and executes creative and strategic initiatives to adapt to changing market trends and complex global challenges. \nThe position will report to the Head of Chemistry, Manufacturing, and Controls (CMC).\n\n\n\nRoles and Responsibilities:\n* Establish the end-to-end global commercial supply chain strategy for Prilenia’s lead product in preparation of launching first approved product. \n* Lead packaging, shipping, and serialization validation in preparation for launch. \n* Provide direction and leadership of Prilenia’s CDMOs and other external partners to ensure on-time delivery of products that comply with regulatory, legal and quality standards. \n* Serve as internal SME for matters related to commercial manufacturing, demand planning and global logistics. \n* Management of 3PL operations, including distribution and inventory management. \n* Lead and oversee commercial drug product manufacturing plans. \n* Review manufacturing related documentation: production record, protocols, reports. \n* Ensure on-time production and distribution across Drug Substance, Drug Product, Packaging and Labeling. \n* Develop strategies to ensure that commercial supply chain is robust and create risk mitigation plans to ensure that manufacturing timelines are consistent with the company program Responsible for establishing and monitoring manufacturing and demand planning key performance indicators (KPIs). \n* Develop and implement short- and long-term procurement planning strategies toward ensuring 100% availability of raw materials to manufacturing. \n* Manage clinical supply chain in collaboration with relevant internal teams and external vendors (e.g. CROs). \n\n\n\nQualifications:\n* M.Sc. or BA in science and/or engineering (chemistry, pharmacy, engineering or related sciences). \n* 10+ years of extensive experience and demonstrated leadership in clinical and commercial Supply Chain Management and manufacturing. \n* 5+ years’ management experience in a GMP environment with oral solid small molecule products. \n* Ability to manage 3PL provider/s. \n* Experience in EU supply chain and first launch highly preferred. \n\n\n\nSkills:\n* A flexible and innovative problem solver who formulates and executes creative and strategic initiatives to adapt to changing market trends and complex global challenges. \n* Capability to build cross-functional alignment including Quality, Regulatory, Finance, Commercial and Manufacturing partners. \n* Excellent oral, written and interpersonal communications skills to effectively interact, exercise discretion, judgment and diplomacy when dealing with internal and external stakeholders and executive leadership. \n* Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality, and risk. \n* Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives. \n* Team player with a positive attitude and solid leadership skills who can easily handle shifting priorities, multi-tasking in a deadline-oriented environment. \n* Ability to take initiative, be accountable for individual and team results, and motivate self and others to set and achieve very high-performance standards. \n* Must be able to work under pressure, manage time, set priorities and meet deadlines. \n* Experience working effectively in global virtual setting – a must. \n\n\n\nLocation/Time Zones:\n* This is a full-time remote position in the East Coast of the United States (preference for Boston area) or Europe (preference for the Netherlands); occasional in-person/face-to-face meetings will occur.\n* Flexible schedule with interactions across Israel, North America and Europe time zones.\n\n\n\n\n \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Senior, Legal, Sales and Non Tech jobs that are similar:\n\n
$40,000 — $80,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Prilenia is hiring a Remote Director Senior Director Quality
\nAbout Prilenia \nPrilenia Therapeutics, a clinical-stage biotech company focused on the urgent mission of developing novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, is looking for a Senior/Executive Director of Quality to join its team in Europe. \n\n\nWe are a flexible, fast-moving team that is quickly advancing a potential therapy poised to have major impact on the lives of patients and their families. Our lead product candidate, pridopidine, holds Orphan Drug Designation in both Huntington’s disease (HD) and Amyotrophic lateral Sclerosis Amyotrophic (ALS) in the U.S. and EU, as well as Fast Track designation from the FDA for the treatment of HD. Prilenia is working on preparing for a potential regulatory filing for HD and for starting a global phase 3 in ALS with pridopidine.\n\n\nPridopidine has the potential to be the first treatment to address HD disease clinical progression. Prilenia also believes pridopidine’s novel mechanism of action as a Sigma-1 receptor agonist gives it potential in numerous other neurological diseases. \n \nAbout the role\nWe seek a highly qualified and experienced professional to join our team as the Head of Quality. This position will provide both overall direction and hands-on operational execution in establishing, implementing, and maintaining a phase-appropriate and continuously evolving Quality Management System (QMS). The ideal candidate will have background in late clinical stage and first commercialization of products including GCP, GMP, GVP and other relevant GxP, with a pragmatic true fit-for-purpose approach.\nThe position will report to the Chief Operating Officer.\n\n\n\nRoles and Responsibilities:\n* Lead the development, implementation, and continuous improvement of a phase-appropriate Quality Management System (QMS), including policies, processes, and procedures.\n* Collaborate with internal functions to assure effective vendor selection, qualification, and oversight to ensure clinical trials and other outsourced GxP activities are conducted in accordance with all relevant laws, regulations, and guidelines.\n* Assess GMP and regulatory compliance risk areas and develop and implement risk mitigation measures.\n* Create, implement, and oversee audit plans for CROs, CDMOs and other GxP vendors. Assess and respond to audit outcomes.\n* Lead preparations for regulatory inspections and ensure ongoing inspection readiness.\n* Provide GCP advice and audit for clinical studies to ensure they are conducted in accordance with FDA, EMA, ICH and other applicable requirements, guidelines and laws.\n* Identify any training requirements to meet the quality standards and ensure training is completed.\n* Maintain and expand regulatory knowledge, to the ICH Principles of GCP, GMP, General Data Privacy Regulation and International GxPs; provide industry leading compliance guidance and quality assurance consultation to internal and external stakeholders.\n* Manage all relevant external QA vendors e.g. quality auditors, consultants, etc.\n\n\n\nQualifications:\n* 10+ years of experience in QA roles with a mix of Biotechnology/Pharmaceutical and/or CMO/CRO companies. At least part of the time should have been in a small to medium sized biotech or pharma company.\n* In-depth understanding and application of GxP principles, concepts, practices, and standards.\n* Demonstrated experience in establishing and managing quality systems in small to mid-sized companies.\n* Thorough understanding of GCP and GMP standards for late clinical and early commercialization stages; as well as of both US and EU requirements. \n* Prior experience and broad range of knowledge in Quality, Compliance, or a combination of experience such as Manufacturing, Quality, and Regulatory - required. In-depth knowledge in international regulatory landscape - preferred.\n* Proven experience in building key metrics, reporting, and enhancing recruitment technology and systems to influence decision-making and provide compelling story telling.\n\n\n\nSkills:\n* Excellent oral, written and interpersonal communications skills to effectively interact, and exercise discretion, judgment and diplomacy when dealing with internal and external stakeholders and executive leadership. \n* Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality, and risk. Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.\n* Pragmatic and practical approach; understanding of “fit for purpose” approach. \n* Team player with positive attitude who can easily handle shifting priorities, multi-tasking in a deadline-oriented environment. Must be able to work under pressure, manage time, set priorities and meet deadlines.\n* Highly independent. \n* Experience working in virtual and global setting.\n* Ability to take initiative, be accountable for individual and team results, motivate self and others to set and achieve very high-performance standards.\n\n\n\nLocation/Time Zones:\n* This is a full-time remote position in Europe. \n* Flexible schedule with interactions across Israel, North America and Europe time zones.\n* Occasional travel is expected.\n\n\n\n\n \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Senior and Senior jobs that are similar:\n\n
$40,000 — $80,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nEurope
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Alpine Immune Sciences is hiring a Remote Senior Director Executive Director Corporate Communications & Investor Relations
\nAlpine Immune Sciences is a leading clinical-stage biopharmaceutical company dedicated to discovering and developing innovative, protein-based immunotherapies for autoimmune and inflammatory diseases. Exciting challenges lie ahead—guided by our core values, we’ll meet these challenges. Join us!\n\n\n\n\nAlpine Immune Sciences is seeking an energetic, passionate, and creative Senior Director/Executive Director, Corporate Communications and Investor Relations reporting to the Chief Business Officer. The successful candidate will work with senior management to develop and lead Alpine’s public relations, corporate communications, and investor relations strategy, manage the Company’s relationships with the investor community, and assist in strategic planning. The Senior Director/Executive Director, Corporate Communications and Investor Relations will align with senior management to build a strategy that communicates and elevates the Company’s mission, messaging, and key events to external stakeholders in the broader biotechnology community. The successful candidate thrives in a fast-paced, dynamic environment and will have proven experience in the design and execution of key events such as quarterly earnings calls and presentations, analyst conferences and events, road shows, press releases, social media, and other corporate activities. This is a critical and visible leadership position within the Company. As such, the successful candidate will work closely with the Chief Business Officer, Chief Financial Officer, and other executives to formulate Alpine’s overall corporate communications and investor relations strategy. \n \nDuties and responsibilities\n \n• Lead creation of corporate and financial communications, including preparation of quarterly earnings press releases and scripts, earnings presentations, Q&A, content for investor presentations, road shows, and board presentations. \n• Manage and update the Company’s corporate presentation and press releases for data releases, scientific meetings, presentations, and publications in close collaboration with Scientific Communications.\n• Manage external consulting relationships and ensure efficiency in external spending. \n• Work collaboratively to establish corporate brand planning, including brand strategy and identity, through management of company website and creation of other branding materials. \n• Oversee and lead all corporate social media activities for Company.\n• Develop a deep and thorough understanding of the Company’s pipeline and corporate strategy; support the delivery of this strategy to both internal and external audiences through clear and compelling written and oral communication, in compliance with corporate policies and securities regulations. \n• Proactively engage with buy-side and sell-side research community. \n• Lead the development and implementation of a targeted investor relations strategy to maximize the Company’s long-term value creation and ensure the consistent presentation of that strategy across all messaging.\n• Act as the liaison for Alpine’s investment banking equity research interactions to effectively leverage sell-side capabilities cross-departmentally while optimizing management time with these stakeholders.\n• Conduct periodic, in-depth, investor targeting exercises and maintain a target investor list.\n• Support financing activities, including implementation of financing strategy, managing relationships within the banking community, and executing financing activities. \n• Maintain the IR calendar, which includes strategic decisions on Company and executive participation in investor conferences, non-deal roadshows and analyst/investor meetings.\n• Ability to travel 10-25% of the time, including occasional off-hours and weekend work for events and medical meetings.\n \nQualifications\n \n• Undergraduate degree in biological sciences and/or engineering.\n• MD and/or PhD in life sciences preferred; MBA desirable.\n• 6-11 years (Senior Director), 12+ years (Executive Director), of successful experience in biotech/pharma investment banking, equity research, management consulting, biotech/pharma corporate strategy, investor relations and/or corporate communications.\n• In-depth understanding of the drug development process, small molecules, biologics, and other platforms in autoimmune and inflammatory diseases.\n• Excellent project management and organizational skills with the ability to prioritize multiple work streams and deadlines, balance opposing priorities and communicate effectively.\n• Excellent written and oral communications skills.\n• Self-starter with initiative and ability to execute once strategies are set.\n• Ability to work collaboratively with internal and external stakeholders in a fast-paced environment.\n• Knowledge of MS Office applications and especially strong in Excel and PowerPoint. \n• Experience/familiarity with social media strategy, tools, and technologies (e.g., X (Twitter), YouTube, and LinkedIn).\n\n\nLI-Remote\n\n\n\n\n\nAt Alpine we engage equitable workplace strategies to ensure fair compensation. Actual compensation is dependent upon current market data, experience, and pay parity within our organization. This position is a Senior Director level position up to an Executive Director, with a compensation range of $235,000 - $260,000 for a Senior Director, and $255,000 - $290,000 for an Executive Director. Note that there is a strong preference for candidates to be located in one of the following five states: CA, MA, NC, OR, or WA. We take care of our employees with a competitive benefits package that includes stock options, annual bonus, premium medical, dental, and vision coverage for employees and their dependents, as well as life and disability benefits, FSA, and 401(k) plans. We believe quality time outside the office is vital to our employees’ satisfaction at work, so our flexible PTO plan of 160 hours, generous holiday time (generally 12 days), and parental benefits encourages team members to take time off so they can come back refreshed. Alpine team members enjoy competitive salaries and equity participation (stock options).\n\n\nAlpinists share a passion for meaningful work and are committed to solving the most complex problems in immunology to create new therapies for patients. We believe in innovative thinking, collaboration, flexibility, bias for action, and healthy debate. To foster our team of outstanding scientists and business professionals, we provide a premier work environment with a state-of-the-art lab and office spaces with truly inspiring views, and an open design to facilitate teamwork.\n\n\nOur treasured culture has been shaped by our diverse team who truly enjoys working and playing together. We nurture Alpine’s culture in many ways, including all-company social events and happy hours, lunch-and-learn and education opportunities, interest groups like book club and movie nights, peer-to-peer recognition programs, a robust wellness program to help support physical, mental, and emotional health, and more.\n\n\nAlpine is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Alpine is also committed to compliance with all fair employment practices regarding citizenship and immigration status.\n\n\nOur office and lab are located in the blossoming biotech neighborhood of Eastlake in Seattle. Alpinists enjoy the flexibility to work onsite, remotely, or a hybrid schedule, with evolving options as we prioritize keeping Alpinists safe and healthy. Onsite employees enjoy an open-office layout with comfortable huddle rooms and Zoom Room-enabled conference rooms, a spacious breakroom and kitchen with a coffee bar and snacks, and rooftop access to enjoy gorgeous views of Lake Union and Gas Works Park.\n\n\nExciting challenges lie ahead—guided by our core values, we’ll meet these challenges. Join us!\n \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Design, Consulting, Education and Senior jobs that are similar:\n\n
$45,000 — $85,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nSeattle, WA or Remote
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Erasca is hiring a Remote Sr Director Clinical Development
\nSenior Director, Clinical Science \n\nPosition Summary: \n\nReporting to the SVP Early Clinical Development, the Senior Director, Clinical Development will support and may lead the clinical aspects of one or more clinical development studies. This person will work closely with cross-functional teams in the management and execution of the Clinical Development Plan (CDP), in developing innovative and efficient solutions to medical and scientific clinical trial issues, and in ensuring the successful execution and completion of clinical trials. The Senior Director, Clinical Science will also have individual study level responsibility for one or more trials. \n\n Essential Duties and Responsibilities: \n\n\nKey clinical deliverables include document development (INDs, Protocols, IBs, applicable regulatory documents, etc.), medical and scientific input into the development of deliverables required for study activation and study conduct (CRFs, SAP, data listings, etc.), data review, and other deliverables as needed. \n\nMay attend and contribute at meetings with Health Authorities (HAs) related to program; develop responses to HAs and IRBs on clinical/medical questions. \n\nRepresent Erasca externally at scientific meetings and congresses. \n\nIn collaboration with other functions and stakeholders, continue to create functional policies and procedures to provide strong and efficient clinical development processes that are scalable and fit for purpose. \n\nPerform all duties in keeping with the Company’s core values, policies and all applicable regulations. \n\n\n\n\nRequired Education and Experience: \n\n\n* Undergraduate degree required; PhD, PharmD, or other relevant advanced degree in a health science field highly preferred. \n\n* At least 10 years of biotech or pharmaceutical industry experience as a clinical scientist or in a closely related clinical development function. \n\n* Experience in oncology clinical trials required; early development experience required, late-stage experience a plus. \n\n* Extensive experience in dynamic start up or small company environments required. \n\n* Demonstrated ability to contribute to strategic clinical planning and work effectively independently and on cross-functional teams. \n\n* Demonstrated ability to evaluate, interpret, and present complex scientific data. \n\n* Deep knowledge of biostatistics, GCP, and regulatory requirements for clinical studies; extensive experience with data analysis and interpretation; understanding of safety and pharmacovigilance principles. \n\n* Proven track record of successfully delivering projects on time, to budget and required quality. \n\n* Excellent verbal and written communication and presentation skills. \n\n* Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment; a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex problems. \n\n* Flexibility, with the willingness and ability to manage through strategic shifts. \n\n* Strong learning orientation, curiosity, and passion for science and patients. \n\n\n\n\n \n\nThe anticipated salary range for this position is $200,000 to $275,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etcetera. In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price. \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Education and Senior jobs that are similar:\n\n
$50,000 — $75,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nSan Diego, California, United States
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Alector is hiring a Remote Senior Director Biostatistics
\nOur mission is to develop therapies that empower the immune system to combat neurodegeneration and our team is focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, a novel portfolio of programs, leading healthcare investors, and pharma company partners, who share in our commitment to bettering the lives of patients and realizing a world where we make brain disorders history \n\n\nWe are looking for a Senior Director, Biostatistics, reporting to the VP of Biostatistics and Analytical Programming. As the Biostatistics Senior Director, you will collaborate with R&D functions to support robust and efficient study designs, develop comprehensive analysis plans, and lead the delivery of study data analysis results. You will be the expert statistical leader providing oversight and strategic feedback for the clinical programs assigned to you. The Senior Director, Biostatistics, will drive the development and implementation of statistical strategy to effectively support drug development You will directly impact company success by increasing the strength of study designs, interpretability of results, Regulatory strategy & interactions, and by implementing innovative methods to improve efficiency & quality of clinical development.\n\n\n\n\n\nYour priorities will include:\n* As the lead Biostatistician for assigned projects and ensure effective, timely and compliant management and delivery of project goals and accountabilities.\n* Define the statistical strategy and ensure appropriate statistical methodologies are applied to study designs and data analyses for clinical trials.\n* Provide expert statistical input and consultancy to Phase I – IV global clinical trials, lifecycle management activities as well as translational medicine research efforts.\n* Ensure a high degree of rigor is applied to the statistical and scientific decision-making process and outcomes.\n* Collaborate with internal and external collaborators in study design, analysis, reporting, interpretation, and communication of clinical trial results.\n* Author and review critical documents such as briefing documents, protocols, SAP, top-line reports, CSR, and integrated summaries.\n* Support the project team and clinical study team including the derivation of go/no-go criteria, summary reports, and results interpretation.\n* Participate in FDA and other regulatory body interactions (IND/CTA filings, safety reporting).\n\n\n\nWe'd love to hear from you if you have:\n* Ph.D. in Statistics or related discipline with 10+ years, or MS with 15+ years of proven experience in the biotechnology or related industry, including interaction and submission experiences with both FDA and EMA.\n* Successful project and people management and expertise in the development of CNS diseases.\n* Thorough knowledge of life cycle management; consistent track record of innovatively applying statistical principles, theories, and concepts to clinical drug development leading to regulatory approvals.\n* Deep hands-on operational experiences in Biostatistics deliverables, including study design, protocol development, CRFs, clinical databases, Statistical Analysis Plans (SAP), SDTM/ADaM datasets, and CSR Tables/Figures/Listings.\n* Up to date knowledge of industry and academic developments in the Neuroscience, and apply them to clinical study design and analysis.\n* Demonstrated innovative and flexible ability and mindset to work in a changing and demanding environment. Exercise good judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards.\n* Demonstrated strong leadership, project management, collaboration, communication, and organization skills.\n* Advanced programming skills in SAS, R and other relevant statistical software solutions.\n* Detailed knowledge of adaptive designs, Bayesian methodology, trial simulation, and complex modeling.\n* Innovative problem-solving capabilities, the agility to respond promptly and completely to time-critical tasks.\n\n\n\n\n$250,000 - $290,000 a yearBase salary ranges will be determined by the candidate’s level, qualifications, skill set, and experience.\n\n#LI-BL1\n#LI-Remote\n\n\nAt Alector, our vision is bold, people are our priority, and our values are at the core of everything we do. Our dynamic and flexible environment encourages our teams to experiment, take ownership of decisions, and question convention to solve complex problems. We value shared wins, perseverance, and a growth mindset, which drives us forward, together. \n\n\nAlector was named on Fortune’s "Best Workplaces in Biopharma" top list for small and medium-sized companies for the third consecutive year! And we moved up from #16 to #11 in 2022. \nAmong the things you'll discover at Alectorfrom your very first day are our committed and driven colleagues, a bold company vision, and new, modern offices designed to inspire innovation and collaboration in South San Francisco, right at the heart of Biotech Bay. Our benefits are thoughtfully designed around Alectorians and their loved ones and include flexible hybrid work options, competitive compensation, and comprehensive and unique benefits that enhance your health and well-being. Come join us! \n \nWe believe that hard-working teams include people from a wide variety of backgrounds and experiences who can challenge each other’s assumptions with fresh perspectives and bring creative ideas to the table. We are committed to building an open, diverse, and inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, sexual orientation, age, marital status, veteran status, or disability status, or any other characteristics protected under applicable federal, state, or local laws. \n\n\nWe will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation. \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Design and Senior jobs that are similar:\n\n
$45,000 — $85,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nUnited States
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