Director, Supply Chain

Role Summary

Director, Supply Chain responsible for leading and developing the clinical drug supply strategy and management of all supply chain activities to support global Phase I–III studies, including forecasting, inventory, IRT configuration, and CMO management. Collaborates with Clinical Development and Clinical Operations to understand study requirements and develop IP forecasts, and leads continuous improvement of core supply chain processes for clinical and commercial operations.

• Lead and develop the clinical drug supply strategy, planning and management of all supply chain activities required to support global Phase I – III clinical studies including forecasting, supply planning, IRT configuration, inventory management and CMO management
• Collaborate with the Clinical Development and Clinical Operations teams from protocol development through final study design to understand study requirements and assumptions needed to set up the supply chain and develop the IP forecast
• Participate in Clinical Sub Team (CST) meetings, Study Team meetings, Project Team meetings and present Supply Chain updates to the cross-functional team
• Develop expert-level understanding of the IRT system used to manage site activation, IP site shipments, monitor patient enrollment, patient visits, determine trends and execute adjustments
• Manage internal and external touchpoints and maintain communication to ensure adequate clinical drug supply for global trials while ensuring cGMP and regulatory compliance
• Provide commercial supply chain support in collaboration with Manufacturing, Quality and Commercial teams including serialization expertise, and the release and distribution of commercial product from 3PL to authorized trading partners in compliance with DSCSA
• Participate in the creation and maintenance of clinical and commercial SOPs and Work Instructions and related documentation
• Lead continuous improvement initiatives with the IMSC team and cross-functional partners to standardize and streamline core supply chain processes for clinical and commercial programs
• Support financial planning for global clinical studies including budgeting, forecasting and strategic planning

• 8–10 years pharmaceutical/biotechnology supply chain planning and forecasting experience, preferably in a manufacturing or commercial environment
• 3–5 years of leadership experience in pharmaceutical/biotechnology industry with a proven track record of leading teams and delivering results
• Experience managing complex global supply chain operations including vendor partnerships and contract negotiations, ensuring compliance with cGMP regulations
• Experience collaborating with Manufacturing, Quality and CMO’s including providing a 12–24 month rolling forecast of drug product requirements, managing production schedules and coordinating FG deliveries
• Comprehensive knowledge of CMC requirements/activities including development, validation, regulatory and quality timelines
• Technical degree or equivalent (BS/MS), preferably in Supply Chain or IT

• Technical degree or equivalent (BS/MS), preferably in Supply Chain or IT