Description

You will lead end-to-end global supply chain strategy, execution, and governance across all phases of development, including clinical supply and commercial launch preparation, ensuring uninterrupted, compliant, and cost-effective supply of therapeutics. You will build and scale a best-in-class supply organization, partner cross-functionally, and drive supply risk management, forecasting, and readiness for key milestones.

Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or related field (advanced degree preferred).
• 18+ years of experience in Pharmaceutical/Biotech supply chain.
• 7+ years of senior leadership experience managing global teams and vendors.
• Demonstrated experience managing clinical supply for global Phase 3 clinical trials.
• Demonstrated experience transitioning supply chain organizations from clinical to commercial launch in a biotech/small company environment.
• Proven ability to operate effectively in high-complexity, fast-paced biotech environments.
• Experience supporting biologic, gene therapy, or specialty ophthalmology products preferred.
• Strong background in managing constrained or high-risk supply scenarios preferred.
• MBA or advanced scientific degree a plus.
• Executive presence and strategic thinking.
• Strong cross-functional influence without direct authority.
• Exceptional problem-solving and risk-mitigation skills.
• Data-driven decision making and forecasting expertise.
• Ability to balance speed, quality, and compliance.
• Clear, confident communicator with internal and external stakeholders.

Responsibilities

• Define and execute global supply strategy across early- and late-stage programs, including Phase 1-3, commercial launch, and post-approval commitments.
• Serve as enterprise leader for clinical trial supply governance, risk management, and scenario planning.
• Build a commercial-ready supply chain organization to support product launch.
• Provide senior-level input into development timelines, enrollment strategies, and global expansion plans based on supply feasibility.
• Anticipate and mitigate supply risks (manufacturing capacity, comparator shortages, import/export constraints, depot limitations).
• Drive BLA-enabling supply chain activities including shipping validation, commercial labeling processes, and temperature monitoring strategies.
• Support combination device strategy and launch forecasting/planning.
• Oversee end-to-end clinical supply execution: demand forecasting, packaging, labeling, distribution, depot strategy, inventory management, and rescue medication sourcing.
• Balance supply needs with financial considerations including cost, expiration dating, and enrollment projections.
• Build commercial supply chain organization including demand forecasting, pack and label for US/global launch, 3PL selection, depot forecasting, cold-chain network, shipping validation, serialization, and ERP system selection/implementation.
• Select, manage, and govern global supply vendors (CMOs, depots, couriers, comparator sourcing partners) and work closely with global CROs.
• Establish performance metrics, KPIs, and escalation pathways for vendor accountability.
• Negotiate contracts and manage budgets for clinical supply and commercial launch operations.
• Drive continuous improvement and cost optimization across the supply network.
• Partner with Clinical Operations, CMC/Technical Operations, Quality Assurance, Regulatory Affairs, Commercial, and IT teams.
• Act as strategic advisor to program teams and executive leadership on supply-related decisions.
• Ensure full compliance with GMP, GDP, ICH, FDA, EMA, and global regulatory requirements.
• Maintain inspection-ready systems, documentation, and processes, and lead responses to regulatory inspections.
• Build, mentor, and lead a high-performing global supply chain organization.
• Establish scalable processes, SOPs, and operating models; introduce appropriate software tools.
• Foster a culture of accountability, transparency, and proactive problem-solving.