- Lead global clinical supply strategies and execution for assigned clinical programs and studies.
- Translate clinical protocols, enrollment assumptions, country activation plans, dosing regimens, and timelines into demand forecasts and supply plans.
- Develop supply scenarios, risk assessments, inventory strategies, safety stock, resupply, and allocation plans.
- Serve as the clinical supply lead and primary point of accountability for assigned studies and development programs.
- Oversee packaging, labeling, storage, distribution, returns, reconciliation, destruction, and transportation activities.
- Manage IRT strategy, system design, implementation, testing, deployment, maintenance, and study closeout.
- Monitor inventory, expiry, shipment performance, and supply metrics; manage excursions, deviations, discrepancies, and interruptions.
- Ensure compliance with GxP, quality procedures, and regulatory requirements; support audits, inspections, and documentation.
- Coordinate with cross-functional teams and external providers on supply planning, regulatory submissions, and import/export readiness.