Sr Director, CMC Program Management

$252,000 - $275,000/Yr

Denali Therapeutics - South San Francisco, CA

Full-time - Senior

South San Francisco, CA

Professional, Scientific, and Technical Services

About the position

The Sr Director of CMC Program Management at Denali Therapeutics is responsible for leading the selection and management of CROs and CMOs for outsourced development projects. This role involves overseeing CMC project timelines and budgets, managing internal project teams, and ensuring effective communication of risks and project status to senior management. The position requires extensive experience in biotech and pharmaceutical CMC activities, particularly with small molecules and biologics, and emphasizes leadership and collaboration across various teams.

Responsibilities

• Lead CRO/CMO vendor selection process and serve as a point of contact for CROs and CMOs for outsourced development projects
• Represent Denali in issue escalation and resolution with our CMOs/Vendors
• Facilitate, manage, and lead internal CMC project teams
• Establish and maintain CMC project timelines and budgets
• Track CMC deliverables and timelines and ensure the CMC strategies and plans are incorporated into the overall project plans
• Proactively outline risk and mitigations and communicate risks and issues to CMC teams, project teams, and senior management
• Provide regular updates to senior management on project status, timelines, risks, and forecasting for future CMC project needs
• Collaborate with technical leaders, Program Directors, and cross-functional project teams

Requirements

• BA or BS degree in Science, Mathematics, Engineering, or a related scientific discipline
• 12+ years of relevant biotech/pharmaceutical/CMO CMC experience
• 10+ years of management experience
• Direct experience with small molecule and/or biologics CMC
• Extensive experience managing CMC activities at CROs/CMOs
• Extensive technical/functional/development expertise in Drug Substance, Drug Product, Drug Delivery, Analytical or Regulatory
• Drug Substance and Drug Product GMP experience
• Previous line management responsibility
• Command of project management practices and software
• Excellent understanding of the overall drug development process
• Excellent leadership and interpersonal skills

Nice-to-haves

• Advanced degree strongly preferred
• Experience with novel constructs (e.g. bi-specifics, enzyme fusions) strongly preferred
• Experience in effectively working through high-pressure situations; excellent conflict management skills
• Drive to take ownership and responsibility in ensuring the success of the projects and deliverables
• Results and detail-oriented

Benefits

• 401k
• healthcare coverage
• Employee Stock Purchase Plan (ESPP)
• broad range of other benefits