Position located in Boston, MA

Responsibilities of the Senior Clinical Supply Manager:

• Manage the end-to-end clinical supply chain, including forecasting, planning, packaging, labeling, distribution, and inventory management including necessary ancillary materials and equipment.
• Develop and execute comprehensive clinical supply strategies and plans for multiple clinical programs, ensuring alignment with study protocols, timelines, and region-specific regulatory requirements.
• Collaborate with internal stakeholders (clinical operations, regulatory affairs, quality, CMC, etc.) to ensure seamless coordination and execution of clinical supply activities.
• Establish and maintain relationships with external vendors and suppliers, negotiating contracts, managing performance, and ensuring adherence to quality standards.
• Monitor and manage clinical trial material inventory levels, track usage, shelf life dates and disposition of materials across multiple global clinical studies.
• Oversee the labeling and packaging of clinical trial materials, ensuring compliance with relevant regulations and guidelines.
• Implement and maintain robust systems and processes for tracking and documenting clinical supply activities, including batch records, shipping records, and inventory management systems.

Requirements of the Senior Clinical Supply Manager:

• Bachelor’s degree in a scientific field and 8+ years of experience in clinical supply chain management within the pharmaceutical or biotechnology industry.
• Proficiency in specification and use of interactive response technology (IRT) systems.
• Strong understanding of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and relevant regulatory guidelines (e.g., ICH, FDA, EMA).
• Experience with cold chain management for global distribution of clinical products.
• Excellent project management skills with the ability to manage multiple projects simultaneously and prioritize tasks with team and management input.
• Ability to proactively identify and address supply chain issues.