Clinical Supply Chain Manager

Pepgen Corporation - Boston, MA

Full-time - Mid Level

Onsite - Boston, MA

Merchant Wholesalers, Nondurable Goods

About the position

The Clinical Supply Chain Manager will oversee the clinical supply chain for clinical-stage programs, ensuring the timely and efficient delivery of clinical trial materials. This role requires strong project management skills and collaboration with cross-functional teams, focusing on managing clinical supply activities within the pharmaceutical or biotechnology industry.

Responsibilities

• Develop and execute comprehensive clinical supply strategies and plans for multiple clinical programs, ensuring alignment with study protocols, timelines, and region-specific regulatory requirements.
• Manage the end-to-end clinical supply chain, including forecasting, planning, packaging, labeling, distribution, and inventory management including necessary ancillary materials and equipment.
• 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.
• Monitor and analyze clinical supply chain performance metrics, identify areas for improvement, and implement corrective actions as needed.
• Provide regular inventory status updates, guidance and support to project teams regarding clinical supply chain concerns.

Requirements

• Bachelor's degree in a scientific or related field.
• Minimum of 5+ years of experience in clinical supply chain management within the pharmaceutical or biotechnology industry.
• 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.
• Proficiency in specification and use of interactive response technology (IRT) systems.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external partners.
• Attention to detail and a commitment to delivering high-quality work within established timelines.
• Flexibility and adaptability to work in a fast-paced and evolving environment.