Denali Therapeutics is seeking to recruit a leader who will be responsible for organizing and managing CMC strategies, deliverables, and timelines for Denali’s programs, including oversight of contract manufacturing organizations. As a member of the CMC Program Management group, this position is responsible for ensuring 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, working closely with our technical leaders, Program Directors, and cross-functional project teams to successfully integrate CMC deliverables into the overall project timelines.
Key Accountabilities/Core Job Responsibilities:
Organize, manage, and drive CMC strategies, plans, and deliverables for 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 budgets and track CMC deliverables and timelines and ensure the CMC strategies and plans are incorporated into the overall project plans
Proactively outline risks 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 to develop and execute on drug development strategies and plans
Qualifications/Skills:
Typically requires a BA or BS degree in Science, Mathematics, Engineering, or a related scientific discipline, with 12+ years of relevant biotech/pharmaceutical/CMO CMC experience.(or Master’s degree with 10+ years of experience)
An advanced degree and CMC Experience with novel constructs (e.g. bi-specifics, enzyme fusions) is 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 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.
Salary Range: $159,000.00 to $207,000.00 . 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 other benefits. Learn more at https://www.denalitherapeutics.com/careers
This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.
