Vice President, Supply Chain

General Summary

The Vice President, Supply Chain is responsible for the end-to-end strategy, execution, and governance of global supply operations across all phases of development. This role ensures uninterrupted, compliant, and cost-effective supply of investigational and commercial products, comparators, ancillaries, and open-label therapies to support global clinical trials and commercial launch. This leader will build and scale a best-in-class supply organization, partner closely with Clinical Operations, CMC, Regulatory, Quality, and external vendors, and provide senior level oversight of supply risk, forecasting, and readiness in support of critical development and registration milestones.

Note:

The following company information describes products and pipeline candidates.

• Strategic Leadership
  • Define and execute the global supply strategy across early- and late-stage programs, including Phase 1–3, commercial launch, and post-approval commitments
  • Serve as the enterprise leader for clinical trial supply governance, risk management, and scenario planning
  • Provide senior-level input into development timelines, enrollment strategies, and global expansion plans based on supply feasibility
  • Anticipate and proactively mitigate supply risks (manufacturing capacity, comparator shortages, import/export constraints, depot limitations, based on deep experience with global supply chain)
  • Drive BLA-enabling supply chain activities, including shipping validation, planning for commercial labeling processes, and temperature monitoring strategies. Provide support for combination device strategy (such as co-packaging with needles and syringes, pre-filled syringes, and other approaches, including device compatibility strategies), and launch forecasting and planning.
• Operational Oversight
  • Oversee end-to-end clinical supply execution, including:
    • Demand forecasting and supply planning
    • Packaging, labeling, and distribution
    • Depot strategy and inventory management
    • Open-label and rescue medication sourcing (e.g., comparator biologics)
    • Management of drug product inventory, including production needs, regulatory timing, and QP approval for introduction of new lots
    • Balance supply needs with financial ones, including management of cost, expiration dating, potential delays, and clinical enrollment projections
  • Ensure timely and compliant supply to global investigational sites while supporting enrollment acceleration and protocol amendments
  • Lead contingency planning for constrained supply scenarios and high-enrolling sites
• Vendor & Partner Management
  • Select, manage, and govern global supply vendors (CMOs, depots, couriers, comparator sourcing partners), and work closely with global CROs to ensure smooth uptake in new countries
  • Establish performance metrics, KPIs, and escalation pathways to ensure vendor accountability
  • Negotiate contracts and manage budgets for clinical supply operations
  • Drive continuous improvement and cost optimization across the supply network
• Cross-Functional Leadership
  • Partner closely with:
    • Clinical Operations (site activation, enrollment strategy)
    • CMC / Technical Operations (manufacturing timelines, release)
    • Quality Assurance (GxP compliance, audits, inspections)
    • Regulatory Affairs (import/export, labeling, country requirements)
    • Commercial team (BLA and launch planning, commercial supply)
  • Act as a strategic advisor to program teams and executive leadership on supply-related decision-making
• Quality, Compliance & Inspection Readiness
  • Ensure full compliance with GMP, GDP, ICH, FDA, EMA, and global regulatory requirements
  • Maintain inspection-ready systems, documentation, and processes
  • Lead responses to regulatory inspections, audits, and findings related to supply chain
• Team Building & Leadership
  • Build, mentor, and lead a high-performing global supply chain organization
  • Establish scalable processes, SOPs, and operating models appropriate for company growth, including selection and introduction of appropriate software tools
  • Foster a culture of accountability, transparency, and proactive problem-solving
  • Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign…