Associate Director, Clinical Supply Chain Management
About the role
Role Summary
We are seeking a highly motivated and results-oriented individual to join Apogee Therapeutics in an Associate Director, Clinical Supply Chain Management role. In this position, you will be responsible for managing the end-to-end clinical supply chain for multiple clinical programs, ensuring the timely and efficient delivery of investigational products, comparators, and ancillary supplies to support global clinical studies. This role will collaborate closely with cross-functional teams including Clinical Operations and Development, Regulatory Affairs, Manufacturing, Quality, and external partners to manage supply planning, inventory control, distribution, and logistics in compliance with regulatory requirements and Good Manufacturing Practice (GMP) standards. The position is fully remote and reports to a senior member of the Clinical Supply Chain management team.
Key Responsibilities
- Strategic Supply Chain Planning:
- Develop and implement clinical supply strategies to meet study timelines for complex programs that require multinational interactions by reviewing clinical trial synopsis’ and/or protocols to understand IMP supply and demand requirements.
- Prepare demand forecast(s) using simulation and/or forecasting tools, ensuring changes in supply configuration, trial design, enrollment timeline, manufacturing availability, and regulatory requirements are considered.
- Partner with Clinical Operations and other stakeholders to determine demand assumptions, such as number of patients and clinical sites, countries/regions, enrollment rates, etc.
- Collaborate with manufacturing to develop drug product delivery schedules to meet demand.
- Optimize supply chain operations to minimize waste and ensure availability of investigational medicinal products (IMP) and materials while maintaining a low risk profile.
- Establish SOP’s and work instructions required to manage clinical supply.
- Clinical Supply Management:
- Oversee the procurement, packaging, labeling, storage, and distribution of clinical trial materials.