CMC Program Lead (Associate Director) - Biotech Development

Denali Therapeutics Inc; South San Francisco (CA); On-site; USD 159,000 - 207,000; Full time

Job summary

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

Qualifications

• Typically requires a BA or BS degree in Science, Mathematics, Engineering, or a related scientific discipline.
• An advanced degree and CMC experience with novel constructs is preferred.
• 12+ years of relevant biotech/pharmaceutical/CMO CMC experience (or Master’s degree with 10+ years).
• Experience managing CMC activities at CROs/CMOs.

Responsibilities

• Organize, manage, and drive CMC strategies, plans, and deliverables for drug candidates across research to NDA/MAA/BLA submissions.
• Manage CRO/CMO vendor selection and act as primary contact for outsourced CMC projects.
• Lead internal CMC project teams and maintain timelines and budgets.
• Proactively identify risks, communicate issues to CMC teams and senior management.
• Provide regular status updates and collaborate with cross-functional teams on drug development strategies.

Job description

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