Director, Clinical Supply Chain Operations

Role:
Director, Clinical Supply Chain Operations (Clinical Supply Chain)

• Lead global demand planning and ensure successful delivery of investigational material(s) for patients.
• Develop and execute strategic plans for production, packaging, distribution, and clinical supply budgeting.
• Oversee execution of clinical supply activities: demand/production planning, primary/secondary packaging, labeling, distribution, returns, reconciliation, destruction, and logistics.
• Define sourcing strategies and manage strategic supplier relationships (CMOs, CROs, 3PLs, IXRS/IRT, and other providers); lead vendor selection and performance monitoring.
• Establish KPIs/scorecards and governance frameworks for internal and external partners.
• Serve as clinical supply representative on cross-functional project/strategy teams; translate protocols into supply/demand plans, contingency strategies, and risk mitigation.
• Support clinical supply budgets and global financial forecasts.
• Mentor/manage direct reports; build operational structure and talent development.
• Create/review/update SOPs, pharmacy manuals, Investigator Brochures, and handling guidance.
• Support compliance (eTMF, audit readiness), regulatory filings (IND/CTA/IMPD), inspections (SME), risk assessments, and mitigation.
• Collaborate on systems/UAT for supply tracking and randomization support; partner with CMC, Clinical Ops, Quality, Regulatory, and Commercial Supply.
• Support digital transformation and process optimization (forecasting tools, dashboards, AI analytics), resilience/sustainability/operational excellence.
• Oversee depot inventory, labeling strategies, temperature excursion management, import/export logistics, and patient supply continuity.

• Bachelor’s degree in science or business-related field.
• 10+ years leading clinical supply chain and logistics.

• Proven ability in highly matrixed organizations; lead high-performing teams.
• Broad understanding of pharmaceutical development across Clinical/Regulatory/Quality.
• Expert knowledge of drug development phases and applicable project management.
• Extensive experience planning/executing investigational material supply strategies.

• Master’s degree/MBA; some development experience.

• Medical/dental/vision + mental health support; EAP; wellbeing reimbursement.
• Paid time off; fertility/family-forming and caregiver benefits; flexible work.
• 401(k) match; annual equity awards; ESPP; company-paid life/disability.
• Learning Institute, mentorship/networking, and employee resource groups.