The Director of Clinical Supply Chain is responsible for leading the strategy, planning, and execution of global clinical trial supply activities across all phases of development. This role ensures uninterrupted supply of investigational medicinal product (IMP), comparator drugs, and ancillary materials to support clinical trials while maintaining full compliance with global regulatory requirements. The Director oversees end-to-end clinical supply operations including forecasting, manufacturing coordination, packaging, labeling, depot distribution, inventory management, and drug accountability. This position also leads vendor governance and works cross-functionally with Clinical Operations, CMC, Quality, Regulatory Affairs, and Finance to ensure clinical programs are supported by a robust and reliable supply chain. The successful candidate will combine strategic leadership with hands-on execution in a fast-paced biotech environment. Clinical Supply Strategy & Planning • Develop and execute global clinical supply strategies across Phase 1-Phase 3 clinical development programs. • Translate clinical protocols and enrollment assumptions into supply forecasts and operational supply plans. • Design supply strategies for complex trials including multi-arm studies, global trials, and physician-choice arms. • Develop integrated supply plans covering manufacturing, packaging, labeling, distribution, and resupply. • Perform supply risk assessments and scenario planning to mitigate supply interruptions. • Lead demand forecasting and supply modeling using appropriate planning tools and simulation approaches. • Provide clinical supply input during protocol development and study feasibility discussions. Clinical Trial Materials Management • Oversee the end-to-end lifecycle of clinical trial materials from production through distribution and reconciliation. • Manage investigational product supply, including lot tracking, expiry management, and retest date monitoring. • Ensure timely packaging, labeling, and release of clinical trial materials. • Track clinical inventory across manufacturing sites, depots, and clinical sites. • Ensure proper documentation and traceability of all clinical trial materials. • Oversee drug returns, destruction, and final study reconciliation activities. Vendor & External Partner Management • Serve as the business owner for key clinical supply vendors including: • Clinical packaging and labeling providers • Clinical depots and 3PL providers • Comparator sourcing vendors • RTSM / IRT system providers • Clinical manufacturing and distribution partners • Lead vendor selection, contracting, and onboarding processes. • Manage Master Service Agreements (MSAs), Statements of Work (SOWs), and change orders in collaboration with Legal and Finance. • Establish vendor performance metrics and conduct regular business reviews. • Ensure vendors operate in compliance with GxP requirements and study timelines. Clinical Depot & Global Distribution Management • Lead selection and oversight of global clinical depots and distribution partners. • Develop depot strategies to ensure efficient global supply distribution. • Ensure appropriate temperature-controlled logistics and chain-of-custody controls. • Oversee import/export processes and country-specific regulatory requirements for IMP distribution. • Manage depot inventory levels to ensure site readiness and prevent supply shortages. Comparator & Ancillary Supply Strategy • Develop strategies for sourcing comparator drugs required for clinical trials. • Manage procurement of commercially available reference products when manufacturer supply agreements are unavailable. • Oversee procurement and management of ancillary supplies required for clinical trials. • Ensure full regulatory compliance, traceability, and documentation of comparator and ancillary products. IRT / Clinical Supply Systems • Partner with Clinical Operations to design and implement IRT/RTSM systems supporting randomization and supply management. • Define resupply algorithms including site buffer levels, demand assumptions, and resupply triggers. • Monitor ongoing supply performance using system-generated data and analytics. • Ensure alignment between randomization strategies and supply distribution. Inventory Management & Drug Accountability • Establish processes for clinical inventory tracking across manufacturing, depots, and sites. • Ensure accurate investigational product accountability. • Monitor inventory health including expiry management and wastage mitigation. • Oversee reconciliation of clinical supplies at study closeout. Regulatory Compliance & Quality Oversight • Ensure clinical supply activities comply with applicable global regulations including GCP, GMP, and GDP. • Support regulatory submissions requiring clinical supply documentation. • Partner with Quality to support inspections, audits, deviation investigations, and CAPA management. • Maintain SOPs and documentation governing clinical supply operations. Cross-Functional Leadership • Serve as the clinical supply representative on global clinical program teams. • Collaborate with: • Clinical Operations • CMC / Manufacturing • Quality Assurance • Regulatory Affairs • Finance and Procurement • Provide leadership and supply expertise to support clinical development strategy. Budget & Financial Management • Develop and manage clinical supply budgets including packaging, depot operations, comparator procurement, and logistics. • Track supply chain spending against study budgets and forecasts. • Provide leadership with supply cost projections and scenario analyses to support decision making. Qualifications • Minimum 15 years of supply chain experience in the pharmaceutical industry preferred. • Bachelor's or master's degree with 12+ years of relevant global supply chain management experience in the pharmaceutical industry a plus. • Deep experience in global late phase clinical supply is preferred. • Strong understanding of regulatory and technical influences and ability to assess business and financial implications of decisions • In-depth technical operations and quality knowledge as well as applied expertise in GMP and GDP regulated facilities • Experience managing external suppliers such as Clinical Depots, 3PL and Logistics providers • Certified Supply Chain Professional (CSCP) certification a plus. Additional Information The anticipated salary range for candidates is between $200,000-$220,000 in San Diego. The final rate offered to a successful candidate will be dependent on several factors that may include but are not limited to the title, type and length of experience within the job, type and length of experience within the industry, education, etc.