Manager, Clinical Supply Chain Management
Remote
About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless. If this sounds like you, keep reading!
Role Summary
We are seeking a highly motivated and results-oriented Manager, Clinical Supply Chain. Management. In this position, you will be responsible for managing the end-to-end clinical supply chain on single or multiple clinical programs working closely with Clinical Operations, Regulatory Affairs, Quality, Development, Manufacturing, and the clinical supply chain team. This includes leading complex programs that will require multinational interactions, and ensuring changes in supply configuration, trial design, enrollment timeline, manufacturing availability, and regulatory requirements are considered. In this role you will partner with Clinical Operations to monitor and review enrollment plans and actuals for use in developing the supply requirements plans. Additionally, you will coordinate and lead supply activities with both internal and external partners and serve as a key point of contact with multiple functional areas. The position is fully remote and reports to a senior member of the Clinical Supply Chain team.
Key Responsibilities
- Review clinical trial synopsis and/or protocols to understand IMP supply and demand requirements
- Partner with Clinical Operations to determine demand assumptions, such as number of patients, number of sites, number of countries, enrollment rates, etc.
- Create, review, and update the clinical supply and demand plans based on strategic elements/study forecasts from Clinical Operations for studies and/or programs using simulation and/or forecasting tools
- Collaborate …
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Benefits/PerksCompany culture Company culture involvement Dynamic environment Dynamic work environment Exceptional company culture Professional growth
Tasks- Manage clinical supply chain
- Monitor inventory levels
- Oversee project management
Antibody Engineering Biologics Biotechnology Clinical operations Clinical trials Communication Forecasting GMP Immunology Label Development Logistics Management Problem-solving Project Management Quality Quality Assurance R Regulatory Regulatory Affairs Simulation Tools SOP Development Technical Operations
Experience5 years