Design and execute the global supply chain strategy across multiple studies and phases to enable drug development balancing agility, cost-efficiency, and regulatory compliance., Develop and scale supply chain infrastructure and operations to support early-stage clinical development through to late-stage and commercial readiness., Establish best practices and systems for procurement, planning, logistics, and CMO/CRO management, ensuring alignment with Quality, Regulatory, Clinical, and Finance teams., Drive operational excellence through KPI tracking, scenario planning, and process improvement., Lead collaborative demand planning process to ensure uninterrupted clinical supplies: trial forecasting, procurement, and logistics., Oversee end-to-end clinical supply planning: protocol design through manufacturing, packaging, labeling, distribution, and inventory management., Negotiate and manage global vendor relationships (CMOs, CDMOs, 3PLs) and ensure continuity of supply., Execute comparator and combination drug sourcing strategies, Support global regulatory submissions and inspections; ensure all activities meet FDA, EMA, and other international requirements., Ensure all suppliers comply with import/export and regulatory standards., Oversee quality documentation (Deviations, CAPAs, Change Controls, etc.) and support SOP development and continuous improvement for cGxP compliance., Collaborate cross-functionally with Clinical Ops, Technical Ops, QA, Regulatory, Finance, and Program Teams., Build and scale a high-performing supply chain team as the company matures, Manage budgets and contracts
