Senior CMC Program Lead — Drug Development

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

Job summary

Denali Therapeutics in South San Francisco seeks an Associate Director, CMC Program Management to lead CMC strategies, deliverables, and timelines across development stages, including NDA/MAA submissions. You will manage CRO/CMO vendors and guide cross-functional teams to integrate CMC plans into overall program timelines.

The ideal candidate has 12+ years in biotech CMC, proven leadership, and a track record delivering complex programs on time in a fast-paced environment.

Qualifications

• BA or BS with 12+ years of biotech/pharmaceutical/CMO CMC experience (or Master’s with 10+ years)
• Advanced degree with CMC experience in novel constructs preferred
• Experience managing CMC activities at CROs/CMOs is required
• Drug Substance and Drug Product GMP experience is required
• Proficient in project management practices and software
• Strong understanding of the drug development process
• Excellent leadership and stakeholder management with CROs/CMOs
• Ability to perform under high pressure; conflict management skills
• Ownership mindset with results- and detail-oriented approach

Responsibilities

• Organize, manage, and drive CMC strategies, plans, and deliverables across development stages
• Manage CRO/CMO vendor selection and serve as contact for outsourced CMC projects
• Facilitate and lead internal CMC project teams
• Establish and maintain CMC timelines and budgets; track deliverables
• Provide regular updates to senior management on status and risks
• Collaborate with technical leaders and cross-functional teams to shape development strategies

Skills

CMC program management

Project management software

Leadership

Stakeholder collaboration

Risk management

Cross-functional partnership

Education

Bachelor's or Master’s degree in Science/Math/Engineering or related field

Advanced degree preferred

Tools

GMP knowledge

Job description

Denali Therapeutics in South San Francisco seeks an Associate Director, CMC Program Management to lead CMC strategies, deliverables, and timelines across development stages, including NDA/MAA submissions. You will manage CRO/CMO vendors and guide cross-functional teams to integrate CMC plans into overall program timelines.

The ideal candidate has 12+ years in biotech CMC, proven leadership, and a track record delivering complex programs on time in a fast-paced environment.