Associate Director, Clinical Supply Chain

Irvine, California, United States

Reporting to the VP, Manufacturing Operations & Supply Chain, the Associate Director, Clinical Supply Chain will provide strategic leadership and end-to-end oversight of clinical supply activities across the Tarsus development portfolio. This role is accountable for translating clinical development plans and study protocols into integrated global supply strategies that ensure investigational product is available to patients and clinical sites when needed.

The Associate Director will lead supply planning and forecasting, packaging and labeling, interactive response technology (IRT) supply management, inventory and distribution, returns, reconciliation, and destruction for studies from first-in-human through Phase 3, while ensuring compliance, operational readiness, cost effectiveness, and proactive mitigation of supply risks.

• Lead end-to-end clinical supply chain strategy and execution across multiple global development programs, providing operational and people leadership for employees and contingent staff supporting clinical supply activities.
• Translate clinical development plans and study protocols into phase-appropriate supply strategies covering demand forecasting, manufacturing and release requirements, packaging and labeling, distribution, inventory, resupply, returns, reconciliation, and destruction.
• Lead Clinical Supply Team meetings and serve as the primary clinical supply contact for cross-functional planning, issue resolution, risk escalation, and alignment on program and study supply plans.
• Manage, coach, and develop clinical supply personnel; set clear objectives, allocate resources across programs, build functional capabilities, and foster a culture of accountability, collaboration, continuous improvement, and commitment to patients.
• Develop and maintain scenario-based demand forecasts using enrollment assumptions, dosing regimens, randomization, dropout rates, country and site activation plans, shelf life, lead times, and appropriate supply overage; adjust plans as study assumptions evolve.
• Partner with Pharmaceutical Sciences, Technical Operations, Quality, and external manufacturers to align drug-product manufacturing, testing, release, stability, retest and expiry dating, and resupply schedules with clinical demand.
• Develop global packaging and labeling strategies, including kit design, blinding, comparator requirements, label content and translations, country-specific requirements, and relabeling or expiry-extension activities at depots and sites, as needed.
• Define clinical supply requirements for IRT/RTSM systems, including supply algorithms, inventory parameters, user acceptance testing, system implementation, and ongoing oversight of investigational product throughout study execution.
• Select and manage contract packaging organizations, depots, logistics providers, comparator suppliers, and other external partners; establish scopes, budgets, timelines, service expectations, governance, and performance metrics and hold partners accountable for quality, cost, and delivery.
• Oversee global distribution and inventory management, including import and export coordination, cold-chain or temperature-controlled logistics, shipment tracking, depot and site inventory, and evaluation and disposition of temperature excursions.
• Ensure complete and compliant investigational product accountability, returns, reconciliation, and destruction, with timely resolution of inventory discrepancies and maintenance of inspection-ready documentation.
• Develop and maintain SOPs, work instructions, systems, forms, and governance processes for clinical supply management; own or support change controls, deviations, investigations, CAPAs, specifications, and other documentation within the quality management system.
• Represent Clinical Supply on cross-functional program and study teams, collaborating closely with Clinical Development, Clinical Operations, Biostatistics, Regulatory Affairs, Quality Assurance, CMC, Technical Operations, Medical Affairs, Program Management, Finance, Legal, and Procurement to deliver study milestones and resolve supply risks.
• Own clinical supply budgets, vendor forecasts, purchase requirements, and operating plans; identify opportunities to improve processes, systems, service models, packaging configurations, and cost efficiency, and support new-asset planning and…