Senior Director, Clinical Supply Chain

Role: Senior Director, Clinical Supply Chain overseeing global supply strategies for Phase 1–3 biologics clinical trials in a fast-paced biopharma setting. Objectives include ensuring uninterrupted IMP supply, scaling processes for late-stage development, and managing cross-functional collaborations. Responsibilities encompass leading end-to-end clinical supply operations (packaging, labeling, distribution, returns), global logistics planning, vendor management (CDMOs, depots), and compliance with GxP and regulatory standards. Key involvement in clinical documentation, manufacturing alignment, and overseeing regulatory inspections and submissions. Qualifications: Bachelor's in life sciences or related field, 12+ years in biotech/pharma supply chain with 4+ years in leadership, with substantial experience supporting Phase 2/3 biologics trials, particularly in oncology. Expertise needed in global supply logistics, inventory management, vendor oversight, IRT systems, and GxP regulations (21 CFR, Annex 13). High-value specifics include biologics modality, oncology therapeutic area, late-stage clinical development, and global multi-region trial logistics. Stakeholder engagement spans Clinical Ops, CMC, Quality, and Regulatory teams. Work setup is on-site in San Diego, CA, with a comprehensive benefits package and competitive salary. Travel requirements are not explicitly specified.