Director, Clinical Supply Chain
About The Position
The Director of Clinical Supply Chain, reporting to the CSO, will have ownership and oversight of all aspects of the clinical supply chain to ensure uninterrupted and timely clinical drug supply for Sagimet’s clinical programs. This will include supply chain development, global supply demand and inventory management, operations, and oversight of label development, and package manufacturing, and finished product distribution. This hands-on role requires an independent self-starter with extensive experience with clinical supply chain management. The role will preferably be based out of our San Francisco Bay Area office, though remote candidates will also be considered. Occasional travel will be required.
Requirements
- Bachelor’s degree required, Master’s degree or advanced scientific degree is preferred.
- Demonstrated experience supporting Late phase clinical development and global clinical supply chain management experience is required, including direct responsibility for IMP supply.
- Thorough knowledge of Good Manufacturing Practices (GMP) is essential.
- Minimum of 10 to 15 years of biotechnology/pharmaceutical industry, with significant hands-on experience in clinical supply chain management.
- Expertise in late-phase clinical supply chain development and management, inventory management, and third-party logistics oversight. Specifically, experience managing drug supply for a Phase 3 global study.
- Extensive experience managing forecast demands and inventories.
- Strong experience in clinical label development, global shipping, and customs.
- Excellent project management skills.
- Demonstrated successful partnerships with Clinical Operations teams to deliver in the late phase of global drug development.
Responsibilities
- Provide technical, functional, and project leadership to develop and implement Clinical Supply Chain strategies and deliver clinical supplies for complex global Phase 3 studies.
- Work collaboratively with CMC, Clinical Operations, Quality Assurance, Regulatory, Finance and Legal to ensure alignment and execution of clinical supply objectives.
- Evaluate, select, provide oversight, and manage interactions with third-party vendors/providers for IMP labelling and packaging, drug depot services, transportation logistics and IRT. This includes accountability for the initiation, management, and oversight of vendor contracting.
- Translate complex clinical trial designs into accurate demand forecasts, supply plans, and inventory strategies. Proactively manage changing forecasts and drug supply plans as clinical study requirements progress and evolve.
- Lead application of (Interactive Response Technology (IRT) systems in collaboration with Clinical Operations.
- Collaborate with relevant internal and external partners to create packaging design based on clinical study needs.
- Lead the development, review, and approval of study specific, multi-country labels that comply with applicable regulations, SOPs, and Good Manufacturing Practices (GMP).
- Responsible for all financial aspects of clinical supply chain operations, including budgeting, forecasting, strategic planning, tracking the performance of contract service providers, and review/approval of invoices.
- Maintain inspection readiness for activities pertaining to labeling, packaging, and distribution practices; partner with QA to support audits and regulatory inspections.
- Manage drug shipments across the programs, for nonclinical program activities, as well as clinical use.
- Other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Number of Employees
1-10 employees
