Clinical Supply Chain Manager at The Fountain Group
Foster City, CA
About the Job
Location: Foster City, CA 94404
Overview:
Job Requirements:
Education and Experience:
Overview:
- Supply Chain Manager is an enthusiastic team player who will provide expertise in a fast-paced pharmaceutical clinical supplies environment for company’s global clinical trials.
- This role has great exposure to all elements of the clinical supply chain from the protocol design through manufacturing to the ultimate distribution and inventory management of clinical supplies at the clinical sites worldwide.
Job Requirements:
- Responsible for managing supplies for dynamic clinical studies associated with multiple clinical development programs across the lifecycle of the programs (Phase 1, 2, 3, Managed Access).
- Leads end –to-end clinical supply responsibilities including but not limited to protocol interpretation, demand planning, supply planning, distribution, inventory management, label generation and planning and execution of labeling operations at partner contract manufacturing organizations (CMOs).
- Works collaboratively with Clinical Operations, Formulation Process Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory, Outsourced Manufacturing and Project Management partners to develop optimal supply strategies and ensure on time delivery of clinical supplies to initiate and resupply studies with investigational medicinal product (IMP).
- Partners with Quality Assurance to resolve quality-related issues with labels/labeling/distribution vendors in a timely manner and develops holistic corrective actions to prevent recurrence.
- Partner with Regulatory to ensure labels meet global regulatory requirements and filings accurately reflect the global supply chains.
- Oversees labeling/distribution contractor activities and relationships and participates in vendor selection, onboarding, management, issue resolution and continuous improvement.
Education and Experience:
- Bachelor’s degree
- 8+ years of relevant industry experience (preferably in end-to-end clinical supply management including clinical labeling)
- Demonstrates knowledge of global clinical trials and the drug development process
- Knowledge of IRT system setup and functionality and proficiency with Excel modeling
- Strong collaboration and excellent team skills to be successful in cross-functional and multi-cultural teams
- Experience in deviation investigation and CAPA implementation
- Experience in vendor oversight and managing external partnerships and relations