Relaytherapeutics
Manager, Clinical Supply Chain
Cambridge, MA. Posted 24 days ago
The role
You will oversee supply chain operations for clinical trials, including the management of investigational medicinal products and comparators. You will ensure study sites receive necessary products on time and in compliance with regulatory requirements.
What you will do
- Monitor IP inventory levels at depots and clinical trial sites.
- Coordinate import, export, and transportation of clinical trial materials.
- Track shipments to and from clinical sites.
- Support development and approval of English label text, translations, and final label design.
- Oversee packaging and labeling processes at clinical supply vendors.
- Ensure proper storage conditions of investigational products.
- Review and disposition temperature excursions.
- Maintain audit-ready documentation in compliance with cGMPs and FDA/EU regulations.
- Track actual expenses vs POs and quote vendors.
- Facilitate communication with internal teams and external stakeholders.
Required qualifications
- 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.
- Strong interpersonal skills.
- Ability to prioritize tasks in a fast-paced, dynamic environment and manage multiple competing deadlines.
Nice to have
- Previous experience in clinical supply chain roles within a biotechnology or pharmaceutical company.
- Familiarity with IXRS, IRT or other clinical trial management systems
About the company
Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process. They use a Dynamo platform to integrate experimental and computational approaches to drug protein targets.