Role:
The Director, Clinical Supply Chain will implement and maintain an integrated supply strategy across clinical programs to ensure reliable product supply for global oncology trials. Oversees clinical supply management including forecasting, packaging, labeling, distribution, inventory management, and vendor oversight.
Key Responsibilities:
- Lead clinical supply strategy for large, complex Phase III studies and smaller earlier-stage studies.
- Translate clinical protocols, enrollment assumptions, country activation plans, and patient forecasts into integrated supply requirements.
- Lead scenario planning and supply-risk management for enrollment variability, protocol amendments, added countries, and unexpected demand.
- Manage direct outsourcing of packaging, labeling, warehousing, and distribution for clinical materials.
- Oversee clinical label text design, translation, and implementation for global requirements and timelines.
- Develop contingency strategies for manufacturing delays, batch failures, country-specific requirements, supply constraints, and changes in enrollment forecasts.
- Represent Clinical Supply Chain in cross-functional Clinical Operations and Demand Planning meetings to identify and mitigate supply risks.
- Mentor and develop junior clinical supply-chain professionals.
- Collaborate with CMC, Quality, Clinical Operations, Regulatory, Finance, and others as needed.
Desired Experience/Education and Personal Attributes:
- Bachelorβs degree in Supply Chain Management, Operations, Business, Life Sciences, Engineering, or related; advanced degree preferred. APICS certification/coursework desired.
- 10+ years supply-chain experience in pharma/biotech/life sciences, with significant clinical supply experience.
- Phase IβIII clinical development experience.
- Global clinical supply planning, forecasting, packaging, labeling, distribution, and inventory management experience.
- Strong experience managing CDMOs/CMOs/CROs/depots and external partners.
- Experience with ambient and cold chain products.
- Strong analytical/financial/strategic-planning/problem-solving skills; excellent communication.
- Thrives in a fast-paced environment; business travel as required.