Manager, Clinical Supply Chain

Relay Therapeutics•Cambridge, MA

2d•$96,000 - $137,000

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 clinical trial sites receive required products on time and in compliance with regulatory requirements. It requires strong analytical, organizational, and communication skills, and the ability to manage multiple tasks in a dynamic, fast-paced environment. The position monitors inventory at depots and clinical sites; coordinates the import, export, and transportation of clinical trial materials; and tracks shipments. It supports development and approval of English investigational drug label text, translations, and final label designs. The role also oversees vendor packaging and labeling, reviews and approves batch records, ensures proper storage, and reviews and dispositions temperature excursions. The Manager maintains audit-ready documentation and compliance with cGMPs and relevant FDA and EU regulations, tracks vendor expenses against purchase orders and quotes, and collaborates with internal teams and external stakeholders. The role also manages site interactions concerning product returns and destruction and supports UAT for new or updated IXRS/IRT systems.

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 approach 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 manage supply risks and prevent interruptions to study timelines.
Coordinate import, export, and transportation of clinical trial materials, ensuring 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 and translations for investigational drugs, and approval of final label designs in line with regulatory and quality standards.
Oversee packaging and labeling processes at clinical supply vendors, including review and approval of 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/EU regulations.
Track actual expenses against purchase orders and vendor quotes for packaging, labeling, and distribution services.
Facilitate collaboration with Clinical Operations, Regulatory, Quality, vendors, and consultants to support clinical supply activities.
Manage clinical trial site interactions concerning the return and destruction of investigational products.
Support User Acceptance Testing (UAT) for new or updated IXRS/IRT systems, ensuring user requirements and specifications are met.