Associate Director, Clinical Supply Chain Management

Summary

Join Apogee Therapeutics as an Associate Director, Clinical Supply Chain Management to manage the end-to-end clinical supply chain for multiple clinical programs, ensuring timely and efficient delivery of investigational products and ancillary supplies. This role will collaborate closely with cross-functional teams to manage supply planning, inventory control, distribution, and logistics in compliance with regulatory requirements and Good Manufacturing Practice (GMP) standards.

Requirements

• S/M.S. degree in Supply Chain Management, Logistics, Pharmaceutical Sciences, or related field
• 8-10 years of relevant experience in supply chain management and 3-5 years in a leadership role
• Certification in Supply Chain Management or Project Management a plus

Responsibilities

• 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
• Oversee the procurement, packaging, labeling, distribution, and return of clinical trial materials, ensuring quality standards and regulatory compliance
• Manage the label development process
• Manage vendor relationships for outsourced supply chain services, including distribution centers, packaging vendors, and courier services
• Develop IRT User Requirement Specifications and conduct User Acceptance Testing
• Conduct supply chain risk assessments, proactively identifying and mitigating potential disruptions to supply continuity
• Maintain inventory management systems to ensure accurate tracking and traceability of all clinical materials
• Monitor inventory levels at depots and clinical sites through the life of a trial and coordinate resupply efforts to prevent stockouts or overages
• Ensure timely and compliant distribution of IMP to clinical trial sites globally, adhering to country-specific regulations and customs requirements
• Ensure compliance with all regulatory guidelines (e.g., FDA, EMA, ICH) and Good Distribution Practices (GDP) across all clinical supply chain activities
• Support regulatory inspections and audits by maintaining thorough documentation of supply chain activities
• Collaborate with Quality Assurance to manage deviations, CAPAs, and continuous improvement initiatives

Benefits

• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• Flexible PTO
• Two, one-week company-wide shutdowns each year