Manager, Clinical Supply Chain

Relay Therapeutics • Cambridge, MA

2d

About The Position

The Manager, Clinical Supply Chain oversees supply chain operations for clinical trials, including investigational medicinal products (IMPs) and comparators. The role ensures study sites receive necessary products on time and in compliance with regulatory requirements. It requires strong analytical, organizational, and communication skills, along with the ability to manage multiple tasks in a dynamic, fast-paced environment.

Requirements

• BS/BA or equivalent in operations, life sciences, or a health-related field.
• At least 3 years of experience in the pharmaceutical or biotechnology industry, focused on clinical supply chain, clinical trial material management, or related areas.
• Experience with primary and secondary packaging and labeling processes for investigational products.
• Experience with distribution, recall processes, and regulatory requirements for clinical trial materials.
• Strong understanding of cGMPs and FDA and EU regulations governing clinical trials.
• Experience managing CMO contracts and vendor relationships.
• Detail-oriented, with a focus on process optimization and compliance.
• Excellent written and verbal communication skills and ability to collaborate effectively with cross-functional teams.
• Strong interpersonal skills and ability to interact diplomatically with senior management, external vendors, and clinical trial sites.
• Ability to prioritize tasks in a fast-paced, dynamic environment and manage multiple competing deadlines.

Nice To Haves

• Previous experience in clinical supply chain roles within a biotechnology or pharmaceutical company.
• Familiarity with IXRS, IRT, or other clinical trial management systems.

Responsibilities

• Monitor investigational product inventory at depots and clinical trial sites to proactively manage supply chain risks and prevent interruptions to study timelines.
• Coordinate import, export, and transportation of clinical trial materials to ensure timely delivery and regulatory compliance.
• Track shipments to and from clinical sites, ensuring adherence to timelines and quality standards.
• Support development and approval of English label text for investigational drugs, translations, and final label designs, ensuring compliance with regulatory and quality standards.
• Oversee packaging and labeling processes at clinical supply vendors and review and approve batch records.
• Ensure proper storage conditions for investigational products at depots and clinical sites.
• Review and disposition temperature excursions and develop strategies to minimize their impact.
• Maintain audit-ready documentation for clinical supply activities and ensure compliance with cGMPs and relevant FDA and EU regulations.
• Track actual expenses against purchase orders and obtain vendor quotes for packaging, labeling, and distribution services.
• Facilitate communication and collaboration with internal teams, including Clinical Operations, Regulatory, and Quality, and external stakeholders, including vendors and consultants.
• Manage interactions with clinical trial sites regarding the return and destruction of investigational products.
• Support user acceptance testing for new or updated IXRS/IRT systems, ensuring user requirements and specifications are met.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager