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Salary: USD 96,000 - 137,000 / annual
Relay Therapeutics, a clinical-stage precision medicines company, is seeking a Manager of Clinical Supply Chain to oversee supply chain operations for clinical trials. This role is responsible for managing investigational medicinal products (IMPs) and comparators, ensuring study sites receive necessary products on time and in full regulatory compliance.
Key responsibilities include:
- Monitor inventory levels at depots and clinical trial sites to proactively manage supply chain risks and prevent study timeline interruptions
- Coordinate import, export, and transportation of clinical trial materials (CTM) with adherence to regulatory requirements
- Track shipments to and from clinical sites, ensuring compliance with timelines and quality standards
- Support development and approval of English label text for investigational drugs, translations, and final label design
- Oversee 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, developing mitigation strategies
- Maintain audit-ready documentation for all clinical supply activities in compliance with cGMPs and FDA/EU regulations
- Track expenses versus purchase orders and vendor quotes for packaging, labeling, and distribution services
- Facilitate communication and collaboration with internal teams (Clinical Operations, Regulatory, Quality) and external stakeholders (vendors, consultants)
- Manage interactions with clinical trial sites regarding return and destruction of investigational products
- Support User Acceptance Testing (UAT) for IXRS/IRT systems
Requirements:
- BS/BA or equivalent in operations, life sciences, or health-related field
- Minimum 3 years of experience in pharmaceutical/biotechnology industry, with 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 focus on process optimization and compliance
- Excellent written and verbal communication skills with ability to collaborate across cross-functional teams
- Strong interpersonal skills to interact diplomatically with senior management, external vendors, and clinical trial sites
- Ability to prioritize tasks in fast-paced environment and manage multiple competing deadlines
Preferred Qualifications:
- Previous experience in clinical supply chain roles within biotechnology or pharmaceutical company
- Familiarity with IXRS, IRT, or other clinical trial management systems
