Associate Director, CMC Program Lead

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company based in South San Francisco, California that is dedicated to defeating neurodegenerative diseases through rigorous therapeutic discovery and development. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.

The Opportunity

Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and the principles of translational medicine. Denali Therapeutics is seeking to recruit a CMC Program Leader who will be responsible for organizing and managing CMC deliverables and timelines for Denali’s small molecule and biologics programs. The candidate will be responsible for timely and optimal decision making across the CMC portfolio from the research phase through all phases of development, including approval (NDA, BLA, MAA) and commercial. The CMC Program Leader will work closely with our technical leaders, Program Directors, and cross-functional project teams to successfully integrate CMC deliverables into the overall project timelines. The candidate will report to the Sr. Director, CMC Program Leadership.

Key Responsibilities

• Organize, manage, and drive CMC strategies, plans, and deliverables for small molecule and biologic drug candidates from the research, pre-IND, and first-in-human testing phases to all later phases of development, including pivotal Phase 2/3 studies and NDA/MAA/BLA submissions
• Manage CRO/CMO vendor selection process and serve as a point of contact for CROs and CMOs for outsourced CMC projects as well as early stage Biotherapeutics requiring large scale material production
• Facilitate, manage, and lead internal CMC project teams
• Establish and maintain CMC project timelines and 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

Responsibilities

• BA or BS degree in Science, Mathematics, Engineering, or a related scientific discipline, with 12+ years of relevant biotech/pharmaceutical/CMO CMC experience. Advanced degree strongly preferred.
• Direct experience with small molecule or biologics; CMC Experience with novel constructs (e.g. bi-specifics, enzyme fusions) strongly preferred
• Extensive 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 overall drug development process
• Excellent leadership, interpersonal skills and demonstrated ability to build effective working relationships and partnerships with internal team members and collaborators at CROs/CMOs
• 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.

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Salary Range: $178,000.00 to $214,000.00. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of othe