Director, Clinical Supply Chain

Job Description The Director, Clinical Supply Chain is a senior program-level leader within a growing, dynamic Pharmaceutical Development organization. Reporting to the Senior Director, Clinical Supply Chain, the Director is accountable for end-to-end clinical supply strategy and execution across a portfolio of high-priority and complex clinical programs, including late-stage and pivotal studies, from study start-up through close-out and commercial transition. The Director serves as the Clinical Supply Chain representative on program and CMC teams, sets supply strategy for assigned programs, oversees the work of Associate Directors and other team members on those programs, and manages key vendor relationships and program-level budgets. Partnering closely with Clinical Operations, Regulatory Affairs, Quality, Finance, Trade Compliance, and internal and external manufacturing, the Director ensures the uninterrupted, compliant, and cost-effective supply of investigational products to patients at global clinical trial sites, and acts as a deputy for the Senior Director when required. Responsibilities Program and Portfolio Leadership Serve as the accountable clinical supply lead for a portfolio of multiple concurrent clinical programs, with direct ownership of the most complex, global, and late-stage studies. Represent Clinical Supply Chain on program, CMC, and study teams; provide supply chain input to clinical development plans, program timelines, and portfolio decisions. Develop and own program-level clinical supply strategies that integrate trial design, enrollment timelines, manufacturing readiness, and global regulatory requirements. Evaluate clinical trial protocols and study designs early in development and provide expert guidance on supply chain feasibility, cost, and risk. Prioritize supply activities and allocate team resources across assigned programs in alignment with the Senior Director and departmental goals. Escalate program-level supply risks, decisions, and trade-offs to the Senior Director and program leadership with clear recommendations. Supply Planning and Operational Execution Lead the creation and approval of clinical supply and demand plans for assigned programs; set planning assumptions and review plans developed by Associate Directors and other team members. Partner with Clinical Operations to validate demand assumptions and review enrollment plans and actuals; apply simulation tools to optimize supply strategies and drive data-driven decisions. Translate clinical demand into manufacturing, packaging, and labeling requirements and coordinate timing with internal and external manufacturing. Direct packaging and labeling strategies that maximize efficiency, minimize waste, and comply with global regulatory requirements. Provide oversight of U.S. and global distribution, depot and site inventory management, and import/export activities, including controlled substance management in compliance with DEA regulations. Proactively identify supply risks and lead development and execution of mitigation and contingency plans to prevent supply disruptions. Oversee drug returns, reconciliation, destruction, and clinical site close-out processes for assigned programs. Lead IRT/IXRS strategy for assigned programs, including User Requirement Specifications, system design review, and User Acceptance Testing; promote consistent IRT standards across studies. Vendor and Budget Management Serve as the primary operational relationship owner with CMOs, packaging and labeling vendors, depots, third-party logistics providers, and IRT vendors for assigned programs. Define vendor scopes of work, review proposals and change orders, and monitor vendor performance against contracts and KPIs; escalate strategic vendor issues to the Senior Director. Collaborate with Quality Assurance on vendor qualification, audits, and resolution of quality events. Develop, manage, and forecast program-level clinical supply budgets; partner with program…

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