Associate Director, Clinical Supply Chain, Cambridge, MA
Core
Lead end-to-end clinical trial material (CTM) planning, vendor management, packaging, labeling, inventory management, and global distribution operations for investigational products.
Role type
Associate Director, Clinical Supply Chain
Builds
Clinical supply systems, processes, and vendor networks to support future clinical studies in different modalities and therapeutics areas.
Domain
Pharmaceutical/Biotechnology, Clinical Supply Chain
Required skills
Clinical supply chain management, logistics, vendor management, packaging and labeling, inventory management, global distribution, temperature monitoring, GxP compliance, import/export documentation, CRO partnership, IRT/RTSM system implementation, supply chain scalability, quality assurance
Responsibilities
Build and maintain flexible clinical supply models for dynamic demand forecasting; Manage flexible investigational product fulfillment and site replenishment strategies; Author and review Investigational Product Handling and Pharmacy Manuals; Direct secondary packaging, blinding/kitting strategies, and label generation; Select and manage central and regional clinical depots; Implement continuous temperature monitoring solutions and triage temperature excursions; Direct end-of-study IP reconciliation, returns, and authorized destruction workflows; Direct qualified domestic and international shipping vendors and distribution strategies; Serve as primary clinical supply chain liaison to Clinical CROs; Partner with Clinical Operations and IRT providers to design system functional specifications; Structure the transition from early studies to larger, multi-center, randomized trials; Direct technical RFPs, contract negotiations, and performance metrics for clinical packaging/labeling CMOs/CPOs; Ensure all clinical supply activities comply strictly with cGMPs, ICH, GDPs and CGPs.
Seniority
Senior, hands-on IC