find a remote job
work from anywhere

Get new remote Biotech + Director + Senior jobs sent to

Subscribe
×
๐Ÿ‘ฉโ€๐Ÿ’ป Join Remote OK ๐Ÿ‘‹  Log in
General
Remote OK Frontpage ๐Ÿ Remote jobs ๐ŸŒ—  Dark mode ๐Ÿ‘ฉโ€๐Ÿ’ป Hire remote workers ๐Ÿšจ Post a remote job ๐Ÿฑ Compact mode โœ๏ธ Remote work blog new
Top jobs
๐Ÿฆพ  AI Jobs
โฐ Async jobs ๐ŸŒŽ Distributed team ๐Ÿค“ Engineer jobs ๐Ÿ’ผ Executive jobs ๐Ÿ‘ต Senior jobs ๐Ÿค“ Developer jobs ๐Ÿ’ฐ Finance jobs โ™พ๏ธ Sys Admin jobs โ˜•๏ธ JavaScript jobs ๐Ÿ‘ Backend jobs
Companies
๐Ÿšจ Post a remote job ๐Ÿ“ฆ Buy a job bundle ๐Ÿท Ask for a discount Safetywing Health insurance for teams Safetywing Health insurance for nomads
Feeds
๐Ÿ›  Remote Jobs API ๐Ÿชš  RSS feed ๐Ÿช“  JSON feed

Hacker News mode  Hacker News mode

Safe for work mode  Safe for work mode

Other
๐ŸŸข  Uptime (99.99%) ๐Ÿ“ˆ  Pageviews (2.23M/mo) ๐Ÿ“Š Remote work stats new ๐Ÿ‘ท Top remote companies ๐Ÿ’ฐ Highest paying remote jobs ๐Ÿงช State of remote work new
๐ŸŒ  Become a digital nomad
โœจ  Applicant AI
๐Ÿ”ฎ  Web3 Jobs
๐Ÿ“ธ  Photo AI
๐Ÿก  Interior AI
๐Ÿ‡ต๐Ÿ‡น  Get Portuguese residency new
Post a remote job Log in

๐Ÿ‘‰ Hiring for a Remote Biotech + Director + Senior position?

Post a job
on the ๐Ÿ† #1 Remote Jobs board.
Minimum
$0k/year
๐Ÿ’ฐ 401(k)
๐ŸŒŽ Distributed team
โฐ Async
๐Ÿค“ Vision insurance
๐Ÿฆท Dental insurance
๐Ÿš‘ Medical insurance
๐Ÿ– Unlimited vacation
๐Ÿ– Paid time off
๐Ÿ“† 4 day workweek
๐Ÿ’ฐ 401k matching
๐Ÿ” Company retreats
๐Ÿฌ Coworking budget
๐Ÿ“š Learning budget
๐Ÿ’ช Free gym membership
๐Ÿง˜ Mental wellness budget
๐Ÿ–ฅ Home office budget
๐Ÿฅง Pay in crypto
๐Ÿฅธ Pseudonymous
๐Ÿ’ฐ Profit sharing
๐Ÿ’ฐ Equity compensation
โฌœ๏ธ No whiteboard interview
๐Ÿ‘€ No monitoring system
๐Ÿšซ No politics at work
๐ŸŽ… We hire old (and young)
Regions
๐ŸŒ Worldwide
โ›ฐ๏ธ North America
๐Ÿ’ƒ Latin America
๐Ÿ‡ช๐Ÿ‡บ Europe
๐Ÿฆ Africa
๐Ÿ•Œ Middle East
โ›ฉ Asia
๐ŸŒŠ Oceania
Countries
๐Ÿ‡บ๐Ÿ‡ธ United States
๐Ÿ‡จ๐Ÿ‡ฆ Canada
๐Ÿ‡ฌ๐Ÿ‡ง United Kingdom
๐Ÿ‡ฆ๐Ÿ‡บ Australia
๐Ÿ‡ณ๐Ÿ‡ฟ New Zealand
๐Ÿ‡ฎ๐Ÿ‡ณ India
๐Ÿ‡ต๐Ÿ‡น Portugal
๐Ÿ‡ฉ๐Ÿ‡ช Germany
๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands
๐Ÿ‡ธ๐Ÿ‡ฌ Singapore
๐Ÿ‡ซ๐Ÿ‡ท France
๐Ÿ‡ญ๐Ÿ‡ฐ Hong Kong
๐Ÿ‡ง๐Ÿ‡ท Brazil
๐Ÿ‡ฌ๐Ÿ‡ท Greece
๐Ÿ‡ฆ๐Ÿ‡ช United Arab Emirates
๐Ÿ‡ธ๐Ÿ‡ช Sweden
๐Ÿ‡ต๐Ÿ‡ฑ Poland
๐Ÿ‡ช๐Ÿ‡ธ Spain
๐Ÿ‡ฒ๐Ÿ‡ฝ Mexico
๐Ÿ‡บ๐Ÿ‡ฆ Ukraine
๐Ÿ‡ฏ๐Ÿ‡ต Japan
๐Ÿ‡น๐Ÿ‡ญ Thailand
๐Ÿ‡จ๐Ÿ‡ฟ Czechia
๐Ÿ‡ท๐Ÿ‡บ Russia
๐Ÿ‡ฎ๐Ÿ‡ฑ Israel
๐Ÿ‡ซ๐Ÿ‡ฎ Finland
๐Ÿ‡จ๐Ÿ‡ณ China
๐Ÿ‡ฎ๐Ÿ‡ฉ Indonesia
๐Ÿ‡ฆ๐Ÿ‡ซ Afghanistan
๐Ÿ‡ฆ๐Ÿ‡ฑ Albania
๐Ÿ‡ฉ๐Ÿ‡ฟ Algeria
๐Ÿ‡ฆ๐Ÿ‡ธ American Samoa
๐Ÿ‡ฆ๐Ÿ‡ฉ Andorra
๐Ÿ‡ฆ๐Ÿ‡ด Angola
๐Ÿ‡ฆ๐Ÿ‡ฎ Anguilla
๐Ÿ‡ฆ๐Ÿ‡ถ Antarctica
๐Ÿ‡ฆ๐Ÿ‡ฌ Antigua and Barbuda
๐Ÿ‡ฆ๐Ÿ‡ท Argentina
๐Ÿ‡ฆ๐Ÿ‡ฒ Armenia
๐Ÿ‡ฆ๐Ÿ‡ผ Aruba
๐Ÿ‡ฆ๐Ÿ‡น Austria
๐Ÿ‡ฆ๐Ÿ‡ฟ Azerbaijan
๐Ÿ‡ง๐Ÿ‡ธ The Bahamas
๐Ÿ‡ง๐Ÿ‡ญ Bahrain
๐Ÿ‡ง๐Ÿ‡ฉ Bangladesh
๐Ÿ‡ง๐Ÿ‡ง Barbados
๐Ÿ‡ง๐Ÿ‡พ Belarus
๐Ÿ‡ง๐Ÿ‡ช Belgium
๐Ÿ‡ง๐Ÿ‡ฟ Belize
๐Ÿ‡ง๐Ÿ‡ฏ Benin
๐Ÿ‡ง๐Ÿ‡ฒ Bermuda
๐Ÿ‡ง๐Ÿ‡น Bhutan
๐Ÿ‡ง๐Ÿ‡ด Bolivia
๐Ÿ‡ง๐Ÿ‡ฆ Bosnia
๐Ÿ‡ง๐Ÿ‡ผ Botswana
๐Ÿ‡ง๐Ÿ‡ป Bouvet Island
๐Ÿ‡ฎ๐Ÿ‡ด British Indian Ocean Territory
๐Ÿ‡ง๐Ÿ‡ณ Brunei
๐Ÿ‡ง๐Ÿ‡ฌ Bulgaria
๐Ÿ‡ง๐Ÿ‡ซ Burkina Faso
๐Ÿ‡ง๐Ÿ‡ฎ Burundi
๐Ÿ‡ฐ๐Ÿ‡ญ Cambodia
๐Ÿ‡จ๐Ÿ‡ฒ Cameroon
๐Ÿ‡จ๐Ÿ‡ป Cape Verde
๐Ÿ‡ฐ๐Ÿ‡พ Cayman Islands
๐Ÿ‡จ๐Ÿ‡ซ Central African Republic
๐Ÿ‡น๐Ÿ‡ฉ Chad
๐Ÿ‡จ๐Ÿ‡ฑ Chile
๐Ÿ‡จ๐Ÿ‡ฝ Christmas Island
๐Ÿ‡จ๐Ÿ‡จ Cocos Islands
๐Ÿ‡จ๐Ÿ‡ด Colombia
๐Ÿ‡ฐ๐Ÿ‡ฒ Comoros
๐Ÿ‡จ๐Ÿ‡ฌ Congo
๐Ÿ‡จ๐Ÿ‡ฉ DR Congo
๐Ÿ‡จ๐Ÿ‡ฐ Cook Islands
๐Ÿ‡จ๐Ÿ‡ท Costa Rica
๐Ÿ‡ญ๐Ÿ‡ท Croatia
๐Ÿ‡จ๐Ÿ‡บ Cuba
๐Ÿ‡จ๐Ÿ‡ผ Curaรงao
๐Ÿ‡จ๐Ÿ‡พ Cyprus
๐Ÿ‡ฉ๐Ÿ‡ฐ Denmark
๐Ÿ‡ฉ๐Ÿ‡ฏ Djibouti
๐Ÿ‡ฉ๐Ÿ‡ฒ Dominica
๐Ÿ‡ฉ๐Ÿ‡ด Dominican Republic
๐Ÿ‡ช๐Ÿ‡จ Ecuador
๐Ÿ‡ช๐Ÿ‡ฌ Egypt
๐Ÿ‡ธ๐Ÿ‡ป El Salvador
๐Ÿ‡ฌ๐Ÿ‡ถ Equatorial Guinea
๐Ÿ‡ช๐Ÿ‡ท Eritrea
๐Ÿ‡ช๐Ÿ‡ช Estonia
๐Ÿ‡ช๐Ÿ‡น Ethiopia
๐Ÿ‡ซ๐Ÿ‡ฐ Falkland Islands
๐Ÿ‡ซ๐Ÿ‡ด Faroe Islands
๐Ÿ‡ซ๐Ÿ‡ฏ Fiji
๐Ÿ‡ฌ๐Ÿ‡ซ French Guiana
๐Ÿ‡น๐Ÿ‡ฑ East Timor
๐Ÿ‡น๐Ÿ‡ซ French Southern Territories
๐Ÿ‡ฌ๐Ÿ‡ฆ Gabon
๐Ÿ‡ฌ๐Ÿ‡ฒ Gambia
๐Ÿ‡ฌ๐Ÿ‡ช Georgia
๐Ÿ‡ฌ๐Ÿ‡ญ Ghana
๐Ÿ‡ฌ๐Ÿ‡ฎ Gibraltar
๐Ÿ‡ฌ๐Ÿ‡ฑ Greenland
๐Ÿ‡ฌ๐Ÿ‡ฉ Grenada
๐Ÿ‡ฌ๐Ÿ‡ต Guadeloupe
๐Ÿ‡ฌ๐Ÿ‡บ Guam
๐Ÿ‡ฌ๐Ÿ‡น Guatemala
๐Ÿ‡ฌ๐Ÿ‡ฌ Guernsey
๐Ÿ‡ฌ๐Ÿ‡ณ Guinea
๐Ÿ‡ฌ๐Ÿ‡ผ Guinea Bissau
๐Ÿ‡ฌ๐Ÿ‡พ Guyana
๐Ÿ‡ญ๐Ÿ‡น Haiti
๐Ÿ‡ญ๐Ÿ‡ฒ Heard Island and McDonald Islands
๐Ÿ‡ญ๐Ÿ‡ณ Honduras
๐Ÿ‡ญ๐Ÿ‡บ Hungary
๐Ÿ‡ฎ๐Ÿ‡ธ Iceland
๐Ÿ‡ฎ๐Ÿ‡ท Iran
๐Ÿ‡ฎ๐Ÿ‡ถ Iraq
๐Ÿ‡ฎ๐Ÿ‡ช Ireland
๐Ÿ‡ฎ๐Ÿ‡ฒ Isle of Man
๐Ÿ‡ฎ๐Ÿ‡น Italy
๐Ÿ‡จ๐Ÿ‡ฎ Cote d'Ivoire
๐Ÿ‡ฏ๐Ÿ‡ฒ Jamaica
๐Ÿ‡ฏ๐Ÿ‡ช Jersey
๐Ÿ‡ฏ๐Ÿ‡ด Jordan
๐Ÿ‡ฝ๐Ÿ‡ฐ Kosovo
๐Ÿ‡ฝ๐Ÿ‡ฐ Kosovo
๐Ÿ‡ฐ๐Ÿ‡ฟ Kazakhstan
๐Ÿ‡ฐ๐Ÿ‡ช Kenya
๐Ÿ‡ฐ๐Ÿ‡ฎ Kiribati
๐Ÿ‡ฐ๐Ÿ‡ต North Korea
๐Ÿ‡ฐ๐Ÿ‡ท South Korea
๐Ÿด Kurdistan
๐Ÿ‡ฐ๐Ÿ‡ผ Kuwait
๐Ÿ‡ฐ๐Ÿ‡ฌ Kyrgyzstan
๐Ÿ‡ฑ๐Ÿ‡ฆ Laos
๐Ÿ‡ฑ๐Ÿ‡ป Latvia
๐Ÿ‡ฑ๐Ÿ‡ง Lebanon
๐Ÿ‡ฑ๐Ÿ‡ธ Lesotho
๐Ÿ‡ฑ๐Ÿ‡ท Liberia
๐Ÿ‡ฑ๐Ÿ‡พ Libya
๐Ÿ‡ฑ๐Ÿ‡ฎ Liechtenstein
๐Ÿ‡ฑ๐Ÿ‡น Lithuania
๐Ÿ‡ฑ๐Ÿ‡บ Luxembourg
๐Ÿ‡ฒ๐Ÿ‡ด Macau
๐Ÿ‡ฒ๐Ÿ‡ฐ North Macedonia
๐Ÿ‡ฒ๐Ÿ‡ฌ Madagascar
๐Ÿ‡ฒ๐Ÿ‡ผ Malawi
๐Ÿ‡ฒ๐Ÿ‡พ Malaysia
๐Ÿ‡ฒ๐Ÿ‡ป Maldives
๐Ÿ‡ฒ๐Ÿ‡ฑ Mali
๐Ÿ‡ฒ๐Ÿ‡น Malta
๐Ÿ‡ฒ๐Ÿ‡ญ Marshall Islands
๐Ÿ‡ฒ๐Ÿ‡ถ Martinique
๐Ÿ‡ฒ๐Ÿ‡ท Mauritania
๐Ÿ‡ฒ๐Ÿ‡บ Mauritius
๐Ÿ‡พ๐Ÿ‡น Mayotte
๐Ÿ‡ซ๐Ÿ‡ฒ Micronesia
๐Ÿ‡ฒ๐Ÿ‡ฉ Moldova
๐Ÿ‡ฒ๐Ÿ‡จ Monaco
๐Ÿ‡ฒ๐Ÿ‡ณ Mongolia
๐Ÿ‡ฒ๐Ÿ‡ช Montenegro
๐Ÿ‡ฒ๐Ÿ‡ธ Montserrat
๐Ÿ‡ฒ๐Ÿ‡ฆ Morocco
๐Ÿ‡ฒ๐Ÿ‡ฟ Mozambique
๐Ÿ‡ฒ๐Ÿ‡ฒ Myanmar
๐Ÿ‡ณ๐Ÿ‡ฆ Namibia
๐Ÿ‡ณ๐Ÿ‡ท Nauru
๐Ÿ‡ณ๐Ÿ‡ต Nepal
๐Ÿ‡ง๐Ÿ‡ถ Caribbean Netherlands
๐Ÿ‡ณ๐Ÿ‡จ New Caledonia
๐Ÿ‡ณ๐Ÿ‡ฎ Nicaragua
๐Ÿ‡ณ๐Ÿ‡ช Niger
๐Ÿ‡ณ๐Ÿ‡ฌ Nigeria
๐Ÿ‡ณ๐Ÿ‡บ Niue
๐Ÿ‡ณ๐Ÿ‡ซ Norfolk Island
๐Ÿ‡ฒ๐Ÿ‡ต Northern Mariana Islands
๐Ÿ‡ณ๐Ÿ‡ด Norway
๐Ÿ‡ด๐Ÿ‡ฒ Oman
๐Ÿ‡ต๐Ÿ‡ธ Palestine
๐Ÿ‡ต๐Ÿ‡ฐ Pakistan
๐Ÿ‡ต๐Ÿ‡ผ Palau
๐Ÿ‡ต๐Ÿ‡ฆ Panama
๐Ÿ‡ต๐Ÿ‡ฌ Papua New Guinea
๐Ÿ‡ต๐Ÿ‡พ Paraguay
๐Ÿ‡ต๐Ÿ‡ช Peru
๐Ÿ‡ต๐Ÿ‡ญ Philippines
๐Ÿ‡ต๐Ÿ‡ณ Pitcairn Island
๐Ÿ‡ต๐Ÿ‡ซ Polynesia
๐Ÿ‡ต๐Ÿ‡ท Puerto Rico
๐Ÿ‡ถ๐Ÿ‡ฆ Qatar
๐Ÿ‡ท๐Ÿ‡ช Reunion
๐Ÿ‡ท๐Ÿ‡ด Romania
๐Ÿ‡ท๐Ÿ‡ผ Rwanda
๐Ÿ‡ธ๐Ÿ‡ญ Saint Helena
๐Ÿ‡ฐ๐Ÿ‡ณ Saint Kitts and Nevis
๐Ÿ‡ฑ๐Ÿ‡จ Saint Lucia
๐Ÿ‡ต๐Ÿ‡ฒ Saint Pierre and Miquelon
๐Ÿ‡ป๐Ÿ‡จ Saint Vincent and the Grenadines
๐Ÿ‡ผ๐Ÿ‡ธ Samoa
๐Ÿ‡ธ๐Ÿ‡ฒ San Marino
๐Ÿ‡ธ๐Ÿ‡น Sao Tome and Principe
๐Ÿ‡ธ๐Ÿ‡ฆ Saudi Arabia
๐Ÿ‡ธ๐Ÿ‡ณ Senegal
๐Ÿ‡ท๐Ÿ‡ธ Serbia
๐Ÿ‡ธ๐Ÿ‡จ Seychelles
๐Ÿ‡ธ๐Ÿ‡ฑ Sierra Leone
๐Ÿ‡ฒ๐Ÿ‡ซ Saint-Martin
๐Ÿ‡ธ๐Ÿ‡ฝ Sint Maarten
๐Ÿ‡ธ๐Ÿ‡ฐ Slovakia
๐Ÿ‡ธ๐Ÿ‡ฎ Slovenia
๐Ÿ‡ธ๐Ÿ‡ง Solomon Islands
๐Ÿ‡ธ๐Ÿ‡ด Somalia
๐Ÿ‡ฟ๐Ÿ‡ฆ South Africa
๐Ÿ‡ฌ๐Ÿ‡ธ South Georgia and the South Sandwich Islands
๐Ÿ‡ธ๐Ÿ‡ธ South Sudan
๐Ÿ‡ฑ๐Ÿ‡ฐ Sri Lanka
๐Ÿ‡ธ๐Ÿ‡ฉ Sudan
๐Ÿ‡ธ๐Ÿ‡ท Suriname
๐Ÿ‡ธ๐Ÿ‡ฏ Svalbard and Jan Mayen Islands
๐Ÿ‡ธ๐Ÿ‡ฟ Swaziland
๐Ÿ‡จ๐Ÿ‡ญ Switzerland
๐Ÿ‡ธ๐Ÿ‡พ Syria
๐Ÿ‡น๐Ÿ‡ผ Taiwan
๐Ÿ‡น๐Ÿ‡ฏ Tajikistan
๐Ÿ‡น๐Ÿ‡ฟ Tanzania
๐Ÿ‡น๐Ÿ‡ฌ Togo
๐Ÿ‡น๐Ÿ‡ฐ Tokelau
๐Ÿ‡น๐Ÿ‡ด Tonga
๐Ÿ‡น๐Ÿ‡น Trinidad and Tobago
๐Ÿ‡น๐Ÿ‡ณ Tunisia
๐Ÿ‡น๐Ÿ‡ท Turkey
๐Ÿ‡น๐Ÿ‡ฒ Turkmenistan
๐Ÿ‡น๐Ÿ‡จ Turks and Caicos Islands
๐Ÿ‡น๐Ÿ‡ป Tuvalu
๐Ÿ‡บ๐Ÿ‡ฌ Uganda
๐Ÿ‡บ๐Ÿ‡พ Uruguay
๐Ÿ Hawaii
๐Ÿ‡บ๐Ÿ‡ฒ USA Minor Outlying Islands
๐Ÿ‡บ๐Ÿ‡ฟ Uzbekistan
๐Ÿ‡ป๐Ÿ‡บ Vanuatu
๐Ÿ‡ป๐Ÿ‡ฆ Vatican City
๐Ÿ‡ป๐Ÿ‡ช Venezuela
๐Ÿ‡ป๐Ÿ‡ณ Vietnam
๐Ÿ‡ป๐Ÿ‡ฌ British Virgin Islands
๐Ÿ‡ป๐Ÿ‡ฎ United States Virgin Islands
๐Ÿ‡ผ๐Ÿ‡ซ Wallis and Futuna Islands
๐Ÿ‡ช๐Ÿ‡ญ Western Sahara
๐Ÿ‡พ๐Ÿ‡ช Yemen
๐Ÿ‡ฟ๐Ÿ‡ฒ Zambia
๐Ÿ‡ฟ๐Ÿ‡ผ Zimbabwe
Apply for this job
๐Ÿ’ต Salary
๐ŸŽช Benefits
๐Ÿ’Š Biotech Remove this filter
โ™พ๏ธ Director Remove this filter
๐Ÿ‘ต Senior Remove this filter
โŒ Clear 13 results

Alpine Immune Sciences


๐Ÿ’ฐ $70k - $105k*

Design

 

Technical

Support

Edu

Strategy

Management

Lead

Marketing

Health

Executive

Alpine Immune Sciences

Apply now

๐Ÿ‘€ 150 views

โœ… 8 applied (5%)

Share this job:
Get a rok.co short link

Alpine Immune Sciences is hiring a
Remote Senior Director Regulatory Affairs

\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 aheadโ€”guided by our core values, weโ€™ll meet these challenges. Join us!\n\n\n\n\nThe Senior Director, Regulatory Affairs is a leader, who provides vision and direction in a fast-paced, dynamic, and competitive drug development environment. They report to the Executive Director of Regulatory Affairs and are responsible for contributing to the global company regulatory strategy and working closely with cross functional leaders in all regulatory interactions and activities for the development of Alpineโ€™s therapeutic candidates. \n \nDuties and responsibilities:\n \nโ€ขLead strategic regulatory activities to support cross functional product development teams in alignment with corporate and program goals.\nโ€ขServe as the global regulatory lead for select development programs.\nโ€ขDevelop and implement regulatory strategy for INDs, CTAs, BLAs; MAAs, NDAs; identify opportunities globally for expedited development. \nโ€ขProvide strategic regulatory input on clinical, including therapeutic indication(s), study designs, patient populations, pediatric development; CMC; and nonclinical development. \nโ€ขPrepare and coordinate authoring, review, and submission of high-quality regulatory documents, including Information Requests, IND/CTA submissions, BLAs/MAAs/NDA, Annual Reports/DSURs, briefing books for health authority interactions, clinical documents to ensure they are complete, well-written, and meet all relevant regulatory requirements. This may involve writing relevant sections of documents.\nโ€ขLead regulatory aspects of clinical study executing including management of correspondence with health authorities and coordination with partner companies and vendors.\nโ€ขEnsure compliance of all Alpine activities with applicable global regulations, standards, and clinical practice guidelines. \nโ€ขMonitor regulatory developments within the industry globally, evaluate impact to Alpineโ€™s programs, and provide actionable guidance to internal and external partners to adapt to and address the developments. \nโ€ขIdentify and communicate with senior management and cross-functional teams regarding potential regulatory issues; propose risk mitigation strategies and resolutions. \nโ€ขLeads continuous improvement efforts on existing department processes and strategies, providing recommendations in areas of expertise.\nโ€ขSupervise, mentor, and help develop the strategic and technical expertise of regulatory colleagues within the Alpine organization.\n \nQualifications:\n \nโ€ขBS/BA degree (or equivalent) in a relevant scientific field required, with an advanced degree preferred.\nโ€ข10+ years of experience in biotechnology or pharmaceutical industry with hands on experience and knowledge of the drug development process and regulatory submission and approval process required.\nโ€ขExperience working in a regulatory affairs leadership role with sole responsibility for a clinical-stage development program and marketing authorization applications, with experience as a manager/supervisor. \nโ€ขLate-stage clinical development experience and experience submitting BLAs, NDAs, and/or MAA is required.\nโ€ขCMC experience, including biologics, is desired.\nโ€ขIn depth knowledge of FDA, EMA, and ICH regulatory requirements and guidelines specific to the areas of clinical research, nonclinical testing, product development, and labeling is required. \nโ€ขMust be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.\nโ€ขDemonstrated ability to develop/maintain strong working relationships with cross-functional internal and external teams, participate on and/or lead multifunctional teams, manage, and prioritize multiple projects and work independently.\nโ€ขPrior global regulatory experience required; experience in Asia Pacific and Latin America is desired.\nโ€ขStrong vendor management experience is desired. \nโ€ขTherapeutic area experience in autoimmune disease is desired.\nโ€ขMust be detail-oriented while also retaining the ability to see the big picture.\nโ€ขMust have effective technical/analytical skills to identify and solve problems independently.\nโ€ขMust be able to work in a fast-paced, timeline-driven environment.\nโ€ขShould have experience writing and developing SOPs.\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 is a Director level position with a compensation range of $230,000 to $270,000. 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 employeesโ€™ 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 Alpineโ€™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 aheadโ€”guided by our core values, weโ€™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, Senior and Marketing jobs that are similar:\n\n $70,000 — $105,000/year\n
\n\n#Benefits\n ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
\n\n#Location\nRemote
Apply for this job

๐Ÿ‘‰ 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.


Adverum Biotechnologies, Inc.


Redwood City, CA
๐Ÿ’ฐ $60k - $145k*

Consulting

 

Technical

Leader

Strategy

Content

Legal

Health

Adverum Biotechnologies, Inc.

Apply now

๐Ÿ‘€ 170 views

โœ… 5 applied (3%)

Share this job:
Get a rok.co short link

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 candidateโ€™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 Companyโ€™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. Adverumโ€™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 ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
\n\n#Location\nRedwood City, CA
Apply for this job

๐Ÿ‘‰ 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


๐ŸŒ Probably worldwide
๐Ÿ’ฐ $83k - $155k*

Controller

 

Design

System

Support

Growth

Travel

Accounting

Financial

Operational

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* Bachelorโ€™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 ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
Apply for this job

๐Ÿ‘‰ 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


๐Ÿ‡บ๐Ÿ‡ธ United States
๐Ÿ’ฐ $60k - $110k*

Manager

 

Technical

Support

Lead

Health

Erasca

Apply now

๐Ÿ‘€ 598 views

โœ… 2 applied (0%)

Share this job:
Get a rok.co short link

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, investigatorโ€™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 Companyโ€™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 ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
\n\n#Location\nSan Diego, California, United States
Apply for this job

๐Ÿ‘‰ 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


๐Ÿ‡บ๐Ÿ‡ธ United States
๐Ÿ’ฐ $100k - $155k*

Growth

 

Travel

Health

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 Immunovantโ€™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 ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
\n\n#Location\nNew York City, New York, United States
Apply for this job

๐Ÿ‘‰ 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


๐ŸŒ Probably worldwide
๐Ÿ’ฐ $60k - $110k*

React

 

Technical

Support

Software

Microsoft

Leader

Management

Legal

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 Immunovantโ€™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 Immunovantโ€™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 Immunovantโ€™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 โ€œout of the boxโ€\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 ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
Apply for this job

๐Ÿ‘‰ 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


๐Ÿ‡บ๐Ÿ‡ธ United States
๐Ÿ’ฐ $50k - $85k*

System

 

Microsoft

Management

Lead

Operations

Health

Healthcare

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, Parkinsonโ€™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 peopleโ€™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 Cerevelโ€™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 Cerevelโ€™s global clinical trials transparency and disclosure capabilities\n* Lead the development of Cerevelโ€™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, Investigatorโ€™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+ yearsโ€™ 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 ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
\n\n#Location\nBoston, MA (Remote)
Apply for this job

๐Ÿ‘‰ 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


Seattle, WA or Remote
๐Ÿ’ฐ $45k - $85k*

Design

 

Support

Travel

Edu

Microsoft

Management

Operations

Recruitment

Educational

Alpine Immune Sciences

Apply now

๐Ÿ‘€ 915 views

โœ… 90 applied (10%)

Share this job:
Get a rok.co short link

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 aheadโ€”guided by our core values, weโ€™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 ALPNโ€™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 \nโ€ข 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 ALPNโ€™s clinical development programs. \nโ€ข Develop a strong understanding of clinical site practices to curate and deliver clinical site engagement strategies \n โ€ข Gathers and shares โ€œBest Practicesโ€ and tactics for rapid patient enrollment among trial sites. \n โ€ข 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.\nโ€ข 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. \nโ€ข Establish process to ensure site staff requests are managed efficiently and effectively, positioning ALPNโ€™s clinical studies as a high priority within investigational site operations.\nโ€ข Collaborates with ALPN Clinical Operations, Clinical Development, and external stakeholders to support study performance and progress.\nโ€ข 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.\nโ€ข Facilitates identification of clinical trial site and community educational needs for ALPN clinical trials.\nโ€ข Participates in ALPN community outreach and engagement activities for ALPN clinical trials.\nโ€ข 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 \nโ€ข At least 5 years clinical trials leadership experience\nโ€ข Previous experience in a CTL, MSL, or similar site-facing role preferred\nโ€ข Strong communication, interpersonal, and relationship management skills\nโ€ข Ability to travel domestically and internationally up to 70%; including travel to ALPN at least 6 times/year\nโ€ข Working knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring\nโ€ข High attention to detail\nโ€ข Ability to set priorities and juggle multiple demands\nโ€ข Ability to think critically and be a proactive problem-solver\nโ€ข Ability to work independently while exercising initiative, flexibility, and sound judgment\nโ€ข Comfortable working with various levels of the company including senior level management\nโ€ข Demonstrated proficiency in Microsoft Word, PowerPoint, and Excel\nโ€ข Ability to operate in alignment with ALPNโ€™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 employeesโ€™ 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 Alpineโ€™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 aheadโ€”guided by our core values, weโ€™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 ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
\n\n#Location\nSeattle, WA or Remote
Apply for this job

๐Ÿ‘‰ 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


๐ŸŒ Probably worldwide
๐Ÿ’ฐ $40k - $80k*

Leader

 

Strategy

Management

Lead

Operations

Legal

Sales

Engineering

Executive

Full-Time

Non Tech

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 Huntingtonโ€™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 pridopidineโ€™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 Prileniaโ€™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 Prileniaโ€™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+ yearsโ€™ 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 โ€“ 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 ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
Apply for this job

๐Ÿ‘‰ 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


Europe
๐Ÿ’ฐ $40k - $80k*

System

 

Training

Travel

Quality Assurance

Management

Lead

Operational

Recruitment

Executive

Full-Time

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 Huntingtonโ€™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 pridopidineโ€™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 โ€œfit for purposeโ€ 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 ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
\n\n#Location\nEurope
Apply for this job

๐Ÿ‘‰ 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


Seattle, WA or Remote
๐Ÿ’ฐ $45k - $85k*

Design

 

Consulting

Support

Analyst

Travel

Financial

Edu

Investment

Investor

Banking

Strategy

Management

Lead

Content

Excel

Branding

Executive

Alpine Immune Sciences

Apply now

๐Ÿ‘€ 728 views

โœ… 32 applied (4%)

Share this job:
Get a rok.co short link

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 aheadโ€”guided by our core values, weโ€™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 Alpineโ€™s public relations, corporate communications, and investor relations strategy, manage the Companyโ€™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 Companyโ€™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 Alpineโ€™s overall corporate communications and investor relations strategy. \n \nDuties and responsibilities\n \nโ€ข 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. \nโ€ข Manage and update the Companyโ€™s corporate presentation and press releases for data releases, scientific meetings, presentations, and publications in close collaboration with Scientific Communications.\nโ€ข Manage external consulting relationships and ensure efficiency in external spending. \nโ€ข Work collaboratively to establish corporate brand planning, including brand strategy and identity, through management of company website and creation of other branding materials. \nโ€ข Oversee and lead all corporate social media activities for Company.\nโ€ข Develop a deep and thorough understanding of the Companyโ€™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. \nโ€ข Proactively engage with buy-side and sell-side research community. \nโ€ข Lead the development and implementation of a targeted investor relations strategy to maximize the Companyโ€™s long-term value creation and ensure the consistent presentation of that strategy across all messaging.\nโ€ข Act as the liaison for Alpineโ€™s investment banking equity research interactions to effectively leverage sell-side capabilities cross-departmentally while optimizing management time with these stakeholders.\nโ€ข Conduct periodic, in-depth, investor targeting exercises and maintain a target investor list.\nโ€ข Support financing activities, including implementation of financing strategy, managing relationships within the banking community, and executing financing activities. \nโ€ข Maintain the IR calendar, which includes strategic decisions on Company and executive participation in investor conferences, non-deal roadshows and analyst/investor meetings.\nโ€ข Ability to travel 10-25% of the time, including occasional off-hours and weekend work for events and medical meetings.\n \nQualifications\n \nโ€ข Undergraduate degree in biological sciences and/or engineering.\nโ€ข MD and/or PhD in life sciences preferred; MBA desirable.\nโ€ข 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.\nโ€ข In-depth understanding of the drug development process, small molecules, biologics, and other platforms in autoimmune and inflammatory diseases.\nโ€ข Excellent project management and organizational skills with the ability to prioritize multiple work streams and deadlines, balance opposing priorities and communicate effectively.\nโ€ข Excellent written and oral communications skills.\nโ€ข Self-starter with initiative and ability to execute once strategies are set.\nโ€ข Ability to work collaboratively with internal and external stakeholders in a fast-paced environment.\nโ€ข Knowledge of MS Office applications and especially strong in Excel and PowerPoint. \nโ€ข 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 employeesโ€™ 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 Alpineโ€™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 aheadโ€”guided by our core values, weโ€™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 ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
\n\n#Location\nSeattle, WA or Remote
Apply for this job

๐Ÿ‘‰ 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


๐Ÿ‡บ๐Ÿ‡ธ United States
๐Ÿ’ฐ $50k - $75k*

Support

 

Edu

Management

Lead

Health

Erasca

Apply now

๐Ÿ‘€ 767 views

โœ… 62 applied (8%)

Share this job:
Get a rok.co short link

Erasca is hiring a
Remote Sr Director Clinical Development

\nSenior Director, Clinical Science \n\nPositionโ€ฏSummary:โ€ฏ \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 Companyโ€™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 onโ€ฏcross-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.โ€ฏ \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 ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
\n\n#Location\nSan Diego, California, United States
Apply for this job

๐Ÿ‘‰ 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

 This job is getting a high amount of applications right now (11% of viewers clicked Apply)

๐Ÿ‡บ๐Ÿ‡ธ United States
๐Ÿ’ฐ $45k - $85k*

Design

 

System

Consultancy

Support

Software

Growth

Leader

Strategy

Management

Lead

Operational

Health

Healthcare

Alector

Apply now

๐Ÿ‘€ 719 views

โœ… 79 applied (11%)

Share this job:
Get a rok.co short link

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 โ€“ 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 candidateโ€™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 Fortuneโ€™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 otherโ€™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 ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
\n\n#Location\nUnited States
Apply for this job

๐Ÿ‘‰ 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.

238ms