Manager/Senior Manager, Clinical Supply Chain
Relay Therapeutics•Cambridge, MA
•$99,000 - $167,000
About The Position
This role is responsible for overseeing the supply chain operations for clinical trials, including the management of investigational medicinal products (IMPs) and comparators. The position is pivotal in ensuring that study sites are supplied with the necessary products on time and in full compliance with regulatory requirements. The ideal candidate will possess strong analytical, organizational, and communication skills, 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.
- Minimum of 3 years of experience in the pharmaceutical/biotechnology industry, with a focus 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, 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, with the ability to collaborate effectively with cross-functional teams.
- Strong interpersonal skills, with the ability to diplomatically interact 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 IRT or other clinical trial management systems.
Responsibilities
- Monitor IP inventory levels at depots and clinical trial sites to proactively manage supply chain risks and prevent any interruptions to study timelines.
- Coordinate the import, export, and transportation of clinical trial materials (CTM) to ensure timely delivery and compliance with regulatory requirements.
- Track shipments to and from clinical sites, ensuring adherence to timelines and quality standards.
- Support Author development and approval of English label text for investigational drugs, translations, and approval of final label design while ensuring compliance with regulatory and quality standards.
- Oversee the packaging and labeling processes at clinical supply vendors, reviewing and approving batch records.
- Ensure proper storage conditions of investigational products at depots and clinical sites.
- Review and disposition temperature excursions and develop strategies to minimize their impact.
- Maintain audit-ready documentation for all clinical supply activities and ensure compliance with cGMPs and relevant FDA/EU regulations.
- Track actual expenses vs PO’s & quotes vendors for packaging, labeling, and distribution services.
- Facilitate communication and collaboration with internal teams (Clinical Operations, Regulatory, Quality) and external stakeholders (vendors, consultants) to ensure smooth execution of clinical supply activities.
- Manage interactions with clinical trial sites regarding the return and destruction of investigational products.
- Support User Acceptance Testing (UAT) for new or updated IRT systems, ensuring that user requirements and specifications are met.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
