Associate Director, CMC Program Mgmt

Key Accountabilities/Core Job Responsibilities: Organize, manage, and drive CMC strategies, plans, and deliverables for drug candidates from research, pre-IND, and first-in-human through later phases, including pivotal Phase 2/3 and NDA/MAA/BLA submissions. Manage CRO/CMO vendor selection; serve as point of contact for outsourced CMC projects and early-stage biotherapeutics requiring large-scale material production. Facilitate, manage, and lead internal CMC project teams. Establish and maintain CMC project timelines and budgets; track deliverables and ensure integration into overall project plans. Proactively outline risks and mitigations; communicate risks/issues to CMC, project teams, and senior management. Provide regular updates to senior management on status, timelines, risks, and future CMC needs. Collaborate with technical leaders, Program Directors, and cross-functional teams to develop and execute drug development strategies and plans. Qualifications/Skills: BA/BS in Science/Math/Engineering or related field with 12+ years relevant biotech/pharma/CMO CMC experience (or Master’s with 10+ years). Advanced degree and CMC experience with novel constructs (e.g., bi-specifics, enzyme fusions) 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 drug development process. Excellent leadership/interpersonal skills; ability to build relationships with internal teams and CRO/CMO collaborators. Strong conflict management; effective under high pressure. Ownership mindset; results- and detail-oriented. Compensation/Benefits: Salary range: $159,000–$207,000. Competitive total rewards package including 401k, healthcare coverage, and ESPP. #J-18808-Ljbffr Denali Therapeutics