Clinical Supply Manager

We are seeking an experienced and highly organized Clinical Supply Manager to join our growing CMC team. As a Clinical Supply Manager, you will be responsible for managing the clinical supply chain for multiple programs and ensuring the timely and efficient delivery of clinical trial materials. This role requires a deep understanding of clinical trial supply management, strong project management skills, and the ability to collaborate effectively with cross-functional teams. The ideal candidate will have a proven track record of successfully 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 considerations, including study design, drug supply forecasting, and packaging requirements

Qualifications

• 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
• Demonstrated experience in end-to-end clinical supply chain management, including forecasting, planning, packaging, labeling, distribution, and inventory management
• 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

About PepGen 

We are a biotechnology company advancing next-generation oligonucleotide therapies for neuromuscular diseases. Our ambition is to unlock the potential of nucleic acid therapeutics by leveraging the drug delivery capabilities of our proprietary Enhanced Delivery Oligonucleotide (EDO) platform. We are applying this technology across a wide range of indications through independent and partnered development pathways and are rapidly growing our team, especially at our U.S. headquarters in Boston, Massachusetts

PepGen is proud to be an equal opportunity workplace and is an affirmative action employer.