Senior Director, Clinical Supply Chain
Essential Functions and Responsibilities
- Lead and develop clinical supply strategies across Phase 1β3 programs
- Ensure uninterrupted supply of investigational medicinal product (IMP) across global, multi-region clinical trials
- Lead end-to-end clinical supply operations: packaging, labeling, distribution, returns, reconciliation, and destruction
- Provide global logistics strategy support (import/export activities and depot strategy) with country-specific labeling and regulatory compliance
- Provide cross-functional leadership and operational oversight across Clinical Operations, Quality, Regulatory, and CMC
- Review/oversee clinical trial documentation (protocols, pharmacy manuals, batch records, drug labels, shipping documentation) and oversee IRT strategy, setup, and execution
- Partner with CMC to align manufacturing schedules with clinical supply needs and scale-up; oversee comparator sourcing as needed
- Select, manage, and oversee external vendors (CDMOs, depots, packaging and logistics providers), including RFPs, SOWs, and performance management
- Partner with QA on vendor qualification, audits, compliance activities, and supply chain SOPs/processes
- Ensure compliance with GxP and global regulatory requirements; support inspection readiness and clinical supply submissions
- Develop and manage clinical supply budgets, forecasts, and spend tracking; provide leadership updates on supply status, risks, and assumptions
- Lead, mentor, and develop a clinical supply team; build scalable processes
Education/Experience/Skills
- Bachelorβs degree in life sciences, supply chain, or related field
- 12+ years biotech/pharma supply chain; 4+ years people management in clinical supply
- Strong Phase 2/3 and global (EU, APAC, Canada) clinical trial experience, including multi-region labeling/distribution
- Biologics experience required; oncology background strongly preferred
- Hands-on leadership in small/mid-size biotech; expertise in clinical supply planning/forecasting/inventory
- Vendor management experience (CDMOs, depots, logistics); strong IRT systems knowledge
- GxP, 21 CFR, and Annex 13 knowledge; oncology preferred
- Experience transitioning early-stage to late-stage; building/scaling in emerging biotech; strong stakeholder and problem-solving skills
Benefits/Compensation
- Annual bonus; stock options/RSUs; ESPP; comprehensive medical/dental/vision and supplemental disability insurance; relocation assistance (as applicable)
Application Instructions
- Not provided.