Associate Director, Clinical Supply Chain

About the Role

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.

Let’s talk about some of the key responsibilities of the role:

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 integration as required.

Perform other related duties as required or assigned.

Factors for Success:

S./M.S. in Supply Chain, Operations, Pharmaceutical Sciences, Life Sciences, Engineering, or another relevant field. APICS certification, formal project management training, and/or Lean Six Sigma certification preferred.

A minimum of twelve (12) years of progressively responsible experience in clinical supply chain, clinical supplies, pharmaceutical operations, or related logistics, including experience supporting multiple global clinical studies across early- and late-stage development.

Demonstrated expertise in clinical supply planning and forecasting, packaging and labeling, inventory management, global distribution, returns, reconciliation, destruction, and investigational product accountability.

Strong working knowledge of applicable cGMP, GDP, GCP, and global clinical-trial supply requirements, including relevant FDA, ICH, EU, and country-specific expectations.

Proven experience implementing and managing IRT/RTSM supply functionality and using ERP, inventory-management, forecasting, or supply-planning systems; Oracle NetSuite experience is a plus.

Experience managing external packaging, labeling, depot, logistics, comparator-sourcing, and distribution partners, with a track record of establishing effective governance and meeting quality, cost, and schedule commitments.

Experience with global temperature-controlled distribution, import/export activities, temperature excursions, shelf-life management, expiry extensions, and relabeling activities.

Demonstrated ability to build scenario-based forecasts, interpret complex study assumptions and inventory data, and translate findings into clear supply decisions, contingency plans, and risk-based recommendations.

Strong vendor-management, project-planning, budget-management, contracting, and negotiation skills, with the ability to manage multiple programs and studies in a fast-moving matrix organization.

Excellent written and verbal communication skills and the ability to influence, align, and make decisions across clinical, scientific, quality, regulatory, supply, finance, and business stakeholders.

A pragmatic, hands-on leadership style, exceptional attention to detail, sound judgment, and the ability to move between strategic planning, people leadership, issue resolution, and operational execution.

Decision Making - Identifies, analyzes, and resolves issues or challenges effectively and efficiently. Demonstrates creativity, decisiveness, and the capacity to implement solutions in a structured and outcome-oriented manner. Navigates uncertainty when there’s not a blueprint for success. Owns their decisions and actions.

Collaboration and Team Building - Builds strong relationships and networks. Is curious about and respectful of different points of view. Cultivates a safe space for discussion readily engaging in group dialogue and debate. Puts the team first.

Outcome Driven - Clearly defines mutual expectations of self and others in a team setting. Adapts to changing business needs. Is determined and resourceful in finding solutions, even when faced with obstacles. Takes appropriate actions, including calculated risks, to ensure obligations are met.

A Few Other Details Worth Mentioning:

The position will be based in our beautiful Irvine office, complete with onsite gym, pool, snacks, drinks, and occasional catered meals. We provide a hybrid work environmen