CMC Program Lead (Associate Director) - Biotech Development
Denali Therapeutics Inc
Denali Therapeutics Inc is seeking a leader to organize and manage CMC strategies, deliverables, and timelines for programs, including oversight of CRO/CMO activities from research through NDA/MAA and commercial phases. The role requires coordinating with technical leaders, program directors, and cross-functional teams to integrate CMC deliverables into project timelines. Qualifications include a BA/BS in a scientific field with 12+ years of biotech/pharmaceutical CMC experience (or Master’s #J-18808-Ljbffr Denali Therapeutics Inc
$159k - $207k
...collaboration of leading scientists, industry... ...and managing CMC strategies, deliverables... ...for Denali’s programs, including oversight... ...through all phases of development, including... ...leaders, Program Directors, and cross-functional... ...years of relevant biotech/pharmaceutical/CMO...SuggestedContract workLocal area$261k - $304.5k
## Senior Director, CMC Lead Product DevelopmentApplylocations: South San... ...opportunity to transform CMC product development into scalable process that... ...strategy for assigned program(s) across the clinical... ...collaborations with other pharma/biotech companies and at the Joint...Suggested$159k - $207k
...Organize, manage, and drive CMC strategies, plans, and... ..., manage, and lead internal CMC project teams... ...technical leaders, Program Directors, and cross-functional... ...develop and execute drug development strategies and plans.... ...with 12+ years relevant biotech/pharma/CMO CMC...Suggested- Vir Biotechnology, a clinical-stage biopharmaceutical company, seeks an Associate Director of CMC Project Management to lead cross-functional CMC programs from early development through regulatory filings and lifecycle management. Based in San Francisco, the role requires...Suggested3 days per week
- ...withcardioendocrinediseases. The company’s lead program, MAR001, is being... ...approaching Phase 3 development. Our second clinical... .... The Associate Director, Device Development... ...with internal CMC team and project team... ...device development in the biotech, pharmaceutical, or...SuggestedFull time3 days per week
- ...in South San Francisco, CA, is seeking a senior CMC lead to organize, manage, and drive CMC strategies for... ...timelines and budgets are integrated into program plans. The role requires a BA/BS with 12+ years in biotech/pharma CMC, advanced degree preferred, GMP experience...
- ...Therapeutics seeks a Senior Manager to lead cross-functional planning and execution for pipeline programs. You will partner with Operations Technology, Clinical Development, Regulatory, and QA to ensure... ...delivery. The role emphasizes CMC knowledge and supports Clinical Development...
$188k - $215k
...pioneered a “moneyball for biotech” approach, pooling... ...teams of experts to lead the way. We build... ...Do Senior Manager / Associate Director, CMC Regulatory Sciences reports... ..., and Analytical Development) and Regulatory Affairs... ...throughout a program’s life cycle. Author...Work at officeLocal areaRemote workFlexible hours- ...Rigel Pharmaceuticals, Inc. is seeking a Senior Director, Program Management to lead cross-functional drug development programs from strategy to execution. You will partner with clinical, regulatory, CMC, nonclinical, commercial and other functions to align plans, build...Remote work
$190k - $230k
...we create, and our mission's urgency. The Associate Director/Director, Clinical Development Program Management is a senior leadership role... ...This individual works closely with Core Team Leads, Clinical Development, CMC, Regulatory Affairs, Biometrics, Quality, Pharmacovigilance...Local area- ...senior leadership position manages clinical development programs from early through late-stage trials,... ...compliance. Responsibilities Lead strategic and operational execution of clinical... ...-functional collaboration skills across Clinical, CMC, Regulatory, and Finance...
- ...San Francisco, CA, seeks a Director of siRNA CMC to lead end-to-end strategy and... ...will supervise DS/DP through development, tech transfer, and... ...processes in a fast-paced biotech setting. The ideal candidate... ...+ years in CMC with siRNA programs, strong GMP/QA background,...
$175k - $225k
The Associate Director / Director of Analytical Development will lead and build the analytical strategy and infrastructure... ...in a fast‑paced biotech environment allowing... ...Analytical Strategy & Program Leadership Develop and... ...Contribute to overall CMC strategy and development...$162.5k - $227.5k
...cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple... ...an experienced project manager to lead, coordinate, and drive cross-functional CMC activities supporting early-stage development programs. This individual will partner closely...Full timeWork at officeRemote workWork visa3 days per week$200k - $225k
...neuroscience, we are pioneering the development of potential therapies to... ..., a novel portfolio of programs, leading healthcare investors, and pharma... ..., platform, development, CMC, and other teams to advance... ...Francisco, right at the heart of Biotech Bay. Our benefits are...Local areaFlexible hours- Nektar Therapeutics in the Bay Area seeks a Sr. Project Manager to lead CMC development programs, coordinating cross-functional teams from process development to regulatory submission. You will develop integrated project plans, drive execution, and ensure timely delivery...
- Vivodyne seeks a Senior Program Manager, Client Delivery to lead the operational delivery of complex client programs across scientific, technical, and commercial teams. You will translate work plans into executable schedules, maintain clear communication, surface risks...Full time
- Associate Director Analytical Development & Quality Control Department/Group: Chemistry, Manufacturing & Controls... ...of immune diseases and cancer. Our lead program, soquelitinib, is a first-in-class... ...will serve as a key member of the CMC team, directing internal laboratory...Full timeWork at officeImmediate start
- ...Vir Biotechnology seeks an Associate Director of CMC Project Management to lead cross-functional development programs from early-stage through commercialization. The role coordinates manufacturing, analytical, quality, and regulatory teams while driving process improvements...
- ...Position: Senior Manager/Associate Director, CMC Project Management... ...Management to lead integrated CMC project... ...clinical supply, late-stage development, and commercial... ...stakeholders. Support program budgeting, forecasting... ...preferred. 8-12 years of biotech or pharmaceutical...Full time
$200k - $215k
...is seeking an experienced Associate Director, Pharmaceutical Development to provide technical and strategic... ...clinical and commercial programs for small molecules. This individual will lead formulation and process... ...Supply Chain and Regulatory CMC to develop scientifically sound...Local area$204k - $281k
About This Role:As the CMC Asset Lead, you will be an integral part of... ...Nephrology team, focusing on the development and launch of Biogen's... ...in matrix leadership across program teams and the full product life... ....Experience in healthcare, biotech, or pharmaceutical industries...Full timeTemporary workLocal area$180k - $241k
...partnerships with leading global... ...global clinical development. Our unique business... ...Primary Function: The Associate Director, Regulatory Affairs... ...activities for assigned programs across regions.... ...Medical Writing, CMC, and other... ...promotion of women in biotech. We have achieved...Remote workWorldwideRelocation package- ...Structure TherapeuticsPosted: 2026-10-03Structure Therapeutics is seeking an Associate Director of Medical Writing to lead the development of regulatory and clinical documents for its drug programs. The role requires expertise in regulatory writing, QC, and cross‑...
$187.8k - $208.6k
Shape the CMC regulatory path for Nurix's small... ..., from clinical development through marketed lifecycle... ..., with room at the Associate Director level to own strategy... ...strategies for assigned programs (drug substance and... ...overall pharmaceutical/biotech industry experience...Local area- ...Biotechnology, Inc. is seeking an Associate Director of Research Project... ..., with a focus on leading discovery and preclinical programs across cross-functional... ...execution for early development programs. The ideal candidate... ...complex programs in biotech/pharma, including...Remote work
- ...IDEAYA Biosciences is seeking an Associate Director of Clinical Supply Chain to manage... ...CTM supply for multiple clinical programs. This onsite role partners with CMC, QA, Clin Dev/Clin Ops,... ...vendors, optimizing forecasting, and leading strategic supply initiatives to support...
$139.43k - $232.38k
# Associate Director, Clinical Development Project Manager - OncologyGSK · AnywhereFULL-TIMERemotePosted... ..., freeing functional leads to focus on clinical... ...within pharmaceutical/biotech R&D or clinical... ...Advanced Degree • Project/Program Management Professional (...For contractorsWork at officeLocal areaRemote work2 days per week3 days per week- ...Marea Therapeutics, Inc. in South San Francisco seeks an Associate Director of Device Development to lead the device component of two lead programs. You will drive design controls, verification, risk management, and regulatory content for combination products across CDMO...
$175k - $190k
Associate Director, Development Outsourcing Boston; Remote; San Francisco; Seattle About Jade Biosciences... ...needs in autoimmune diseases. Jade’s lead candidate, JADE101, targets the cytokine... ...across clinical development programs from Phase I through Phase IV. The successful...Contract workRemote work
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