Associate Director, CMC Program Mgmt
Denali Therapeutics
September 02, 2026
Remote friendly (South San Francisco, CA)
United States
Operations
Key Accountabilities / Core Job Responsibilities
- Organize, manage, and drive CMC strategies, plans, and deliverables for drug candidates from research, pre-IND, and first-in-human through later development phases, including pivotal Phase 2/3 studies and NDA/MAA/BLA submissions.
- Manage CRO/CMO vendor selection; serve as point of contact for outsourced CMC projects and early-stage biotherapeutics requiring large-scale material production.
- Facilitate, manage, and lead internal CMC project teams.
- Establish and maintain CMC timelines and budgets; track deliverables and timelines and integrate CMC plans into overall project plans.
- Proactively outline risks and mitigations; communicate risks/issues to CMC, project teams, and senior management.
- Provide regular updates to senior management on status, timelines, risks, and forecasting for future CMC needs.
- Collaborate with technical leaders, Program Directors, and cross-functional teams to develop and execute drug development strategies and plans.
Qualifications / Skills
- BA/BS in Science/Math/Engineering or related field with 12+ years relevant biotech/pharma/CMO CMC experience (or Master’s with 10+ years).
- Advanced degree and CMC experience with novel constructs (e.g., bi-specifics, enzyme fusions) preferred.
- Experience managing CMC activities at CROs/CMOs required.
- Drug Substance and Drug Product GMP experience required.
- Command of project management practices and software.
- Thorough understanding of the drug development process.
- Excellent leadership/interpersonal skills; ability to build relationships with internal teams and CRO/CMOs.
- Conflict management; effective in high-pressure situations.
- Ownership mindset; results- and detail-oriented.
Compensation / Benefits
- Salary range: $159,000.00 to $207,000.00.
- Total rewards include 401k, healthcare coverage, and ESPP.
Application Instructions
- Learn more at https://www.denalitherapeutics.com/careers
- Organize, manage, and drive CMC strategies, plans, and deliverables for drug candidates from research, pre-IND, and first-in-human through later development phases, including pivotal Phase 2/3 studies and NDA/MAA/BLA submissions.
- Manage CRO/CMO vendor selection; serve as point of contact for outsourced CMC projects and early-stage biotherapeutics requiring large-scale material production.
- Facilitate, manage, and lead internal CMC project teams.
- Establish and maintain CMC timelines and budgets; track deliverables and timelines and integrate CMC plans into overall project plans.
- Proactively outline risks and mitigations; communicate risks/issues to CMC, project teams, and senior management.
- Provide regular updates to senior management on status, timelines, risks, and forecasting for future CMC needs.
- Collaborate with technical leaders, Program Directors, and cross-functional teams to develop and execute drug development strategies and plans.
Qualifications / Skills
- BA/BS in Science/Math/Engineering or related field with 12+ years relevant biotech/pharma/CMO CMC experience (or Master’s with 10+ years).
- Advanced degree and CMC experience with novel constructs (e.g., bi-specifics, enzyme fusions) preferred.
- Experience managing CMC activities at CROs/CMOs required.
- Drug Substance and Drug Product GMP experience required.
- Command of project management practices and software.
- Thorough understanding of the drug development process.
- Excellent leadership/interpersonal skills; ability to build relationships with internal teams and CRO/CMOs.
- Conflict management; effective in high-pressure situations.
- Ownership mindset; results- and detail-oriented.
Compensation / Benefits
- Salary range: $159,000.00 to $207,000.00.
- Total rewards include 401k, healthcare coverage, and ESPP.
Application Instructions
- Learn more at https://www.denalitherapeutics.com/careers