\nRole Summary:\n\nThe Associate Director of Supply Chain Planning is responsible for inventory planning and tracking for Dyne’s end-to-end external supply chain, maintaining a production plan that includes long range planning (LRP), ensuring continuous clinical supply, and commercial launch readiness builds and scenario planning for our assets. This role is instrumental in executing our current supply planning and in helping us develop and implement our future capabilities There role collaborates closely with Process Development, Research, CMC, and Quality Control and Quality Assurance. The person in this role is a strategic and results-driven professional with experience in collaborative supply chain planning.   \n\nThis role is based in Waltham, MA without the possibility of being a remote role. Applicants must be able to relocate to the area.\n\nPrimary Responsibilities Include:\n\n\n* Collaborate with CMC, Logistics, Quality Control, Quality Assurance, and Clinical Operations to develop and maintain a valid demand and supply plan, ensure the availability of products for patients, and support the company’s business objectives\n\n* Maintain an understanding of external manufacturing site capacities, capabilities, and supply risks\n\n* Optimize supply chain processes and drive efficiency\n\n* Scenario planning of demand and supply assumptions as we drive to commercialization\n\n* Lead monthly demand and supply planning meetings with cross functional team members as part of our drive to a formal Integrated Business Planning / Sales and Operations Planning process\n\n* Perform analysis of Dyne portfolio, including inventory projection, supply performance and risks\n\n* Integrate with other global planning processes to monitor key performance indicators (KPIs) and analyze supply chain data to identify opportunities for improvement and cost savings (e.g. Demand, Inventory, Sales and Operations Planning process and Key Performance Indicators )\n\n* Author Supply Chain-related standard operating procedures (SOPs) and work instructions\n\n* Work within Interactive Response Technology(s) to verify and adjust clinical site and depot inventories\n\n* Manage relationships with third-party suppliers and vendors to ensure timely delivery of materials and components\n\n* Implement risk mitigation strategies to address supply chain processes and streamline operations\n\n* Ensure compliance with regulatory requirements and quality standards in supply chain operations\n\n\n\n\nEducation and Skills Requirements:\n\n\n* Bachelor's Degree in Engineering, Supply Chain, Business or related field, or equivalent with 8+ years of related work experience in a biotechnology company\n\n* Ability to effectively plan, prioritize, execute, follow up and anticipate challenges\n\n* Experience managing complex schedules and priorities in dynamic pharmaceutical, biotech or related environments\n\n* Ability to work, influence, and gain agreement across multiple functions (Manufacturing, Quality and CMC)\n\n* Strong analytical, problem solving and critical thinking skills\n\n* Strong knowledge of supply chain best practices, inventory management, and demand forecasting\n\n* Expertise in use of MS Excel, as well as demonstrated proficiencies in Smartsheet, Visio, ERP systems and Power BI (or similar application)\n\n* Collaborative work style to be part of a team to identify process gaps and develop solutions\n\n* Excellent interpersonal, verbal, and written communication skills\n\n* Advanced analytical and problem-solving skills\n\n* Experience in working with CMC Teams\n\n* Experience in supply chain, drug development, project management, and/or pharmaceutical manufacturing/packaging\n\n* In-depth working knowledge of regulations relating to clinical manufacturing, packaging and distribution activities (CGMP, GCP)\n\n* APICS or CSCMP certification a plus\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 Sales and Non Tech jobs that are similar:\n\n $47,500 — $81,250/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

\nAre you ready to take ownership of Gordian’s unique in vivo screening platform, and evolve it into an even more powerful tool for predicting patient outcomes? You will be managing an interdisciplinary team of experts with a focus on operational excellence in executing screens, while finding ways for in vivo answers to improve both early and later stages of drug development for complex diseases.  \n\n\nThe Destination:\n\n\nGordian Biotechnology is a therapeutics company whose mission is to cure age-related diseases and ultimately allow people to lead longer, healthier lives. \n\n\nTraditional ex vivo screening methods have failed to produce effective treatments, as age-related diseases have complex causes that include interactions with the aged environment. \n\n\nTo address this problem, Gordian’s platform is the first and only to enable pooled in vivo tests at scale in our proprietary “patient avatars”. We are able to deliver and test hundreds of therapeutics in individual animals, and scale efficacy testing to cover every therapeutic target at the beginning of the drug discovery process (more info on our website). We can choose targets that really impact disease biology, to develop and commercialize therapies for the world’s deadliest diseases, and eventually for the processes of aging itself. \n\n\nThe Journey:\n\n\nOur mission is audacious, and the path will be full of both challenges and excitement. Two things characterize the Gordian experience: 1) We work as a team, with ownership in our own roles and trust in each other. 2) We strive for extraordinary outcomes, and in doing so grow our skills and capability. \n\n\nTeam – Relying on each other begins with transparency. We set clear goals, visibly connecting individuals and teams to our company objectives. This empowers each of us to make autonomous decisions about our work, knowing how they will affect the bigger picture. Our communication happens out in the open. We give and receive feedback from a perspective of helping each other grow, share mistakes, and ask for help. \n\n\nExtraordinary – Every day, we ask ourselves ‘How could this process/outcome be even better?’. Knowing our overall mission, we do what we think helps us make the most progress, without asking for permission. We don’t shy away from big challenges or unknown territory, but find a way to excel. Our colleagues are amazing, both at what they do and as people. They inspire us to keep up, to not let them down, and be inspiring in return. \n\n\nLike any cutting-edge research environment, Gordian doesn't believe in a standard 9 to 5 day. We set ambitious project goals and support each other to meet them, while maintaining the balance individuals need to thrive and achieve excellence. Our team is geared towards helping each other out and maintaining a culture of intellectual and social fun. We like getting things done and keep standing meetings to a minimum. This year, in accordance with our unlimited vacation policy, each member took an average of 4.5 weeks of (offline) vacation, not including major holidays. We unwind with weekly team lunches, and support each others’ projects both experimentally and by ‘pre-mortem’ meetings to discuss possible failure modes and experimental design. \n\n\nIf this environment sounds appealing, help us bring it to life. We are at the beginning of a long journey, and want both your ability and your personality along for the ride. Our culture is a source of great pride; it represents both who we are, and who we wish to be. \n\n\nYou can dive deeper here. \n\n\nAbout the Role:\n\n\nYour mission as VP of Platform is to own the application and evolution of Gordian’s mosaic screening platform, leading the team producing transcriptomic data on potential therapeutic targets across MASH, HFpEF, IPF, & Osteoarthritis from our pooled in vivo screens. \n\n\nYour team has been recruited for their expertise and enthusiasm and are already firing on all cylinders. They are always executing multiple overlapping projects demanding a high level of coordination and logistical planning. You must ensure continued operational excellence and efficiency of the team, helping organize and prioritize while balancing execution towards company goals with continuous improvement of processes and exploration of innovative ideas from the team. An important part of your job is to determine which efforts and initiatives are critical to achieving our next milestones, and provide structure for achieving these. \n\n\nMost of your team’s work results in high-dimensional genomics data that requires analysis by our computational team to interpret. You will use your experience and comprehension, in collaboration with our head of data, to ensure that the platform and data teams communicate seamlessly and operate in lockstep to produce and make accessible the data that fuels our company. Under your leadership the team will be integrated both with their collaborators across the company, and have a clear sense of how their work ties to company strategy. You will digest ambiguity and imperfect information to provide your team with clear directions and conditions for having their work contribute to us reaching our shared goals. \n\n\nOur technology is being used to run large Mosaic screens and discover new therapeutic targets, but can be applied to provide scaled in vivo answers to many other questions.  We will count on you to guide evolution of the platform into providing answers that help drug development and decisions about clinical strategy.  This will transform the value of our platform in improving predictive validity in drug development, and cement the promise of our in vivo approach to the world. \n\n\nIn your first month, you’ll build rapport with the Platform team earning their trust and understanding the work of each member as well as the know-how we’ve developed for in vivo screening. You’ll provide guidance and clarity for the team’s work, while identifying  at least one area of strategic improvement for the team or technology and mapping out the right path to accomplish it. \n\n\nBy three months, the platform team is operating smoothly at a scale that is producing 5-10 hits per month, interfacing  effectively with other teams (i.e. computational biology, disease leads) without CSO involvement. Additionally, you will have led the adaptation of our platform to produce data supporting at least one aspect of drug development (outside of target identification) and will have guided the implementation of one or more new methods to improve our cost or time per interpretable result by 20% or more. \n\n\nAbout you:\n\n\nYou have a history of successful execution, both in- and outside of your job description. \n\n\nYou want a chance to do your best work, immerse yourself and excel, alongside people who will inspire you and whom you’ll be excited to spend your days with. \n\n\nYou truly want to play a key role in an early-stage startup screening new targets for intractable diseases of aging: A fast-paced environment full of both uncertainty and new challenges, demanding relentless resourcefulness. \n\n\nYou have experience with strategic technology leadership in biotech (preferably in drug discovery) and setting the direction for an established but evolving platform or suite of technologies. \n\n\nYou have worked at the intersection of molecules and computation and speak computational biology as a first or second language. You’re familiar with genomic datasets and their challenges. \n\n\nYou have’ve got experience managing a collaborative team in a fast-paced environment, and your team members will tell us that you brought out the best in them. You’re a crisp communicator, and are able to seamlessly manage collaboration with cross functional partners and teams. \n\n\nYou are excited to use cutting edge technology to find the best therapeutic targets, and turn those into drugs. You are familiar with pooled screening, barcoding, and the associated pitfalls and challenges, and ideally also with in vivo gene delivery and experimentation. \n\n\nThe Details:\n\n\nGordian aims to provide everything you need to thrive. Beyond our community and science, you’ll have enough equity to be a true stakeholder in the company, competitive salary, full health/dental/vision/life insurance, 401k with match, onsite lunch paid for 3 days a week, an onsite gym, whatever vacation you need to be at your peak, remote work flexibility, and access to world-class mentors and advisors to support your professional growth. Our building is in the heart of the biotech capital of South San Francisco.\n\n\n\n\n$220,000 - $310,000 a year\n \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Testing and Non Tech jobs that are similar:\n\n $45,000 — $76,250/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\nSouth San Francisco, CA

\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

\nScience at Gordian is scaling, and with your help, so will our Chief Scientific Officer (CSO). Gordian is looking for a Scientific Chief of Staff to work as a strategic partner, providing critical support in planning, communication, and decision-making across our scientific teams that will be essential to drive our science forward.\n\n\nThe Destination:\n\n\nAt Gordian Biotechnology, we are on a mission to cure age-related disease, allowing people to lead longer, healthier lives and wake up every morning, more capable than the day before.\n\n\nAge-related diseases have complex causes that include interactions with the aged environment, and traditional ex vivo screening methods have failed to produce compelling targets or effective treatments. To address this problem, Gordian’s platform enables in vivo Mosaic Screening to deliver and test hundreds of therapeutics in individual animals. We select the most clinically relevant Patient Avatars, whose age, physiology and genomics most closely resembles human patients. Using these and other proprietary tools, we can scale in vivo efficacy testing to more targets than have ever been explored by biopharma,  at the very beginning of the drug discovery process (more info on our website). This lets us develop and commercialize therapies with greater chance of impacting the world’s deadliest diseases, and eventually for the processes of aging itself. \n\n\nThe Journey:\n\n\nOur mission is audacious, and the path will be full of both challenges and excitement. Two things characterize the Gordian experience: 1) We work as a team, with ownership in our own roles and trust in each other. 2) We strive for extraordinary outcomes, and in doing so grow our skills and capability. \n\n\nTeam – Relying on each other begins with transparency. We set clear goals, visibly connecting individuals and teams to our company objectives. This empowers each of us to make autonomous decisions about our work, knowing how they will affect the bigger picture. Our communication happens out in the open. We give and receive feedback from a perspective of helping each other grow, share mistakes, and ask for help. \n\n\nExtraordinary – Every day, we ask ourselves “could this process/outcome be even better?”. Knowing our overall mission, we do what we think helps us make the most progress, without asking for permission. We don’t shy away from big challenges or unknown territory, but find a way to excel. Our colleagues are amazing, both at what they do and as people. They inspire us to keep up, to not let them down, and be inspiring in return. \n\n\nLike any cutting-edge research environment, Gordian doesn't believe in a standard 9 to 5 day. We set ambitious project goals and support each other to meet them, while maintaining the balance individuals need to thrive and achieve excellence. Our team is geared towards helping each other out, an orientation best exemplified through the support we provide for each others’ projects, both experimentally as well as through “pre-mortem” meetings to discuss possible failure modes and experimental design. We like getting things done and keep standing meetings to a minimum. \n\n\nWe like to have social as well as intellectual fun, including through weekly team lunches, monthly company happy hours, and regular social events hosted by Gordian for the broader community. We also encourage our colleagues to unwind; this year, in accordance with our unlimited vacation policy, each member took an average of 2.5 weeks of (offline) vacation, not including major holidays.\n\n\nIf this environment sounds appealing, come experience it with us. We are at the beginning of a long journey, and want both your ability and your personality along for the ride. Our culture is a source of great pride; it represents both who we are, and who we wish to be. You can dive deeper here: https://www.gordian.bio/s/Gordian-values.pdf. \n\n\nThe Role:\n\n\nYour primary mission as Scientific Chief of Staff is to be an extension of our CSO, working closely with him to absorb and implement strategic skills and initiatives across the company. \n\n\nYou will be an integral part of our organization, participating in sync meetings, engaging in strategic discussions, and gradually standing in for the CSO in various interactions, relieving them of operational tasks to focus on research and development. \n\n\nYou'll spend a significant amount of your time learning from our CSO to gain key insights into our mission and vision, critical strategic and organizational initiatives and becoming well versed in our culture. This will give you the insight needed to partner with our scientific teams to provide guidance on prioritization, cross-company impact, and other factors required to align our work across teams. \n\n\nYou'll also have a significant role in managing external relationships, communicating with key partners and scientific advisors to enable collaborations and goodwill. You’ll think about and execute ways to build our external brand, through events, social media, and other communications. \n\n\nInternally, you’ll  spend time closely collaborating with our CSO to flesh out and take on projects aimed at broadly improving strategy, collaboration, and culture at Gordian. You’ll combine organization and enthusiasm to successfully jump into challenging and sometimes ambiguous projects, while also removing operational tasks from our CSO and staying on top of company deadlines and strategic dates. \n\n\nIn your first month you will become familiar with our technology and disease programs assisting our CSO in coordinating matrix work. You’ll create a manual capturing scientific, cultural, and organizational onboarding for new employees. Additionally you’ll take over a project to manage Gordian’s Small Business Innovation Research grant work ensuring the necessary meetings are scheduled and experiments are progressing as planned. \n\n\nIn two months, you’ll have developed a strong understanding of Gordian’s strategy for 2024 and are assisting the CSO in overseeing key projects in partnership with our disease leads and functional leads. You’ll have successfully completed one project that is a key rock or blocker for Gordian (examples could include developing a project management handbook, developing a company-visible version of goals/metrics for 2024, etc.)\n\n\nBy three months you will have fully immersed yourself in Gordian’s culture and can take over the majority of preparations and management for a critical brand launch. You have also proven your ability to quickly adapt and handle unexpected responsibilities and challenges that arise, and are seizing unexpected opportunities to support Gordian’s mission.\n\n\nAnd You :\n\n\nYou want a chance to do your best work, immerse yourself and excel, alongside people who will inspire you and whom you’ll be excited to spend your days with. \n\n\nYou want to play a key role in an early-stage startup: A fast-paced environment full of both uncertainty and new challenges, demanding relentless resourcefulness. \n\n\nYou love science, and are committed to ensuring that treatments reach patients in need, but feel that your skills are best suited outside of the lab. You enjoy the “strategy” of science as much as (or maybe more than) the doing of science. \n\n\nYou have a knack for absorbing both ideas and preferences, to rapidly develop a sense of how our CSO would act in a given situation. You have good judgment, good taste, and drive efforts to completion.\n\n\nYou have strong organizational skills, with the ability to manage multiple projects, tasks and timelines. You are comfortable guiding and collaborating across multiple teams.\n\n\nYou have excellent communication skills, both written and visual. Additionally you have a high standard of work and commitment to quality. \n\n\nHaving a moderate understanding or previous work history focused on molecular biology, physiology, and genomics, will be extremely helpful. \n\n\nThe Details:\n\n\nGordian aims to provide everything you need to thrive. Beyond our community and science, you’ll have enough equity to be a true stakeholder in the company, competitive salary, full health/dental/vision/life insurance, 401k with match, onsite lunch paid for 3 days a week, an onsite gym, whatever vacation you need to be at your peak, remote work flexibility, and access to world-class mentors and advisors to support your professional growth. Our building is in the heart of the biotech capital of South San Francisco.\n\n\n\n\n$125,000 - $160,000 a year\n \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Testing and Non Tech jobs that are similar:\n\n $40,000 — $62,500/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\nSouth San Francisco, CA

\n \n\nPosition Summary: \n\nThe Regulatory and Start Up Specialist (RSS) is an experienced professional in regulatory and site start-up activities. Responsibilities will be dependent upon the location of the RSS and include but are not limited to initial and subsequent clinical trial submission to Competent Authorities and IRB/ Ethics Committees, Informed Consent Form review and adaptation, Essential Document collection and quality review, supporting sites on IRB/EC submissions and provide support to the Site Contract Management group in budget and contract negotiation. The RSS may act as Subject Matter Expert for questions by other in-country members (CRAs, CSSs or others) supporting site start-up activities and may contribute to development or revision of country specific tools and guidance documents to ensure compliance with local and international clinical trials regulations and guidelines. \n\nThis is a remote position and employee must reside in Canada.\n\nEssential functions of the job include but are not limited to: \n\n\nResponsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks. \n\nPreparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP. \n\nInteraction with CA/EC for study purposes and handling responses to the CA/EC.  \n\nProviding regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team as relevant. \n\nMaintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.  \n\nPreparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria. \n\nPartner with the assigned site CRA to ensure alignment in communication and secure site collaboration. \n\nPrepare. review and manage collection of essential documents required for site activation/IMP release. \n\nCustomize country/site specific Patient Information Sheet and Informed Consent Forms. \n\nResponsible for/facilitates the translation and co-ordination of translations for documents required for submission. \n\nMaintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables. \n\nAct as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and  other required reviews to secure on time site activation for the assigned sites in the country.  \n\nWhen required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department. \n\nMay participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study. \n\nKeep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PfM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations. \n\nMaintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF \n\nMay support the clinical team performing Pre-Study Site Visits.  \n\nMay support process improvement initiatives, training, and mentoring. \n\nPerforms other duties as assigned by management. \n\n\n\n\nQualifications: \n\nMinimum Required: \n\n\n* Fluent in English and French\n\nBachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience. \n\n1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies \n\n\n\n\nOther Required: \n\n\nStrong communication and organizational skills are essential. \n\nExperience using computerized information systems, electronic spreadsheets, word processing and electronic mail required. \n\nFluency in English and for non-English speaking countries the local language of country where position based. \n\n\n\n\nPreferred: \n\n\nRelevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience for the particular country. \n\nExperience using milestone tracking tools/systems. \n\nAbility to prioritize workload to meet deadlines. \n\nAdvanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science \n\n\n\n\nCompetencies \n\n\nKnowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements. \n\nAbility to follow task-specific procedures, be attentive to detail and place importance on accuracy of information. \n\nStrong organizational skills. \n\nAbility to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located. \n\nAbility to work independently in a fast-paced environment with a sense of urgency to match the pace. \n\nMust demonstrate excellent computer skills. \n\nGood communication, presentation, interpersonal skills, both written and spoken, with an aptitude to learn how to inform, influence, convince, and persuade. \n\nFlexible attitude with respect to work assignments, and new learning. \n\nOccasional travel may be required. \n\n\n\n\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 Non Tech and Non Tech jobs that are similar:\n\n $30,000 — $50,000/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\nMontreal, Quebec, Canada