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Global Clinical Supply Chain Manager
2 months ago
Gilead Sciences, Inc. is a research-based biopharmaceutical company seeking a highly skilled Global Clinical Supply Chain Manager to join our team. As a key member of our organization, you will play a critical role in ensuring the timely and safe delivery of investigational medicinal products (IMP) to clinical trials globally.
Key Responsibilities- Lead the development of strategies and plans for clinical supply management, working collaboratively with cross-functional teams and external partners.
- Manage end-to-end clinical supply chain operations, including demand and supply planning, distribution strategies, and depot inventory management.
- Perform demand and supply forecasting and planning with a planning horizon of 9 to 18 months, translating forecasts into clinical packaging and labeling (CPL) execution plans.
- Develop and implement depot and clinical site seeding and resupply strategies, ensuring accurate inventory and records at depots through timely reconciliation.
- Collaborate with Logistics management and other members of GCSC, PDM, and external partners to resolve shipping-related issues, escalating to senior leadership as needed.
- Support the clinical development and PDM strategies, working collaboratively within GCSC, Quality, and other functional groups to develop clinical supply strategies and plans.
- Maintain compliance of clinical supply deliverables for clinical study reports (CSR) and trial master file (TMF), keeping abreast of all incidents related to shipment and reporting trending to Quality Assurance.
- Responsible for maintaining GDP, GMP, and global trade compliance, maintaining compliance to required training, and obtaining and reviewing quotes, approving purchase requisitions and invoices.
- Bachelor's degree with 7+ years of industry experience, or Master's degree with 5+ years of experience, or PhD or PharmD degree with 0+ years of experience.
- Strong working knowledge and experience in clinical supply management, including forecasting, demand/supply planning, distribution strategies, IVRS, and ERP systems.
- Working knowledge of clinical study designs, blinding practices, global trials, from Phase 1 first-in-human to late phase.
- Working knowledge of Clinical Demand and Operations Planning (CD&OP).
- Experience with managing comparator drugs and other co-meds for clinical studies.
- Ability to collaborate, influence, and negotiate to work effectively with cross-functional teams and external suppliers to meet clinical development timelines and patient needs.
- Excellent verbal, written, and interpersonal communication skills, with the ability to write clear and concise documents/presentations.
- Strong computer skills, including email, word processing, spreadsheet creation and management, online search, and the ability to efficiently adopt systems and databases used at Gilead.
- Ability to manage resources and timelines for complex clinical study and programs, with project management experience a plus.
