Manager, Clinical Supply Chain jobs in United States
cer-icon
Apply on Employer Site
company-logo

Relay Therapeutics · 1 month ago

Manager, Clinical Supply Chain

Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process. The Manager of Clinical Supply Chain will oversee supply chain operations for clinical trials, ensuring timely delivery of investigational products while maintaining compliance with regulatory requirements.

BiotechnologyHealth CareTherapeutics
check
Growth Opportunities

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 IXRS/IRT systems, ensuring that user requirements and specifications are met

Qualification

Clinical supply chain managementCGMPsFDA regulationsClinical trial material managementVendor relationship managementPackagingLabeling processesAnalytical skillsProcess optimizationPrioritization skillsOrganizational skillsCommunication skillsInterpersonal skills

Required

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

Preferred

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

Company

Relay Therapeutics

twittertwittertwitter
company-logo
Relay therapeutics is a developer of an allosteric drug-discovery platform intended to apply computational techniques to protein motion.

Funding

Current Stage
Public Company
Total Funding
$1.4B
Key Investors
Nextech InvestSoftBank Vision FundBiotechnology Value Fund
2024-09-10Post Ipo Equity· $200M
2024-01-08Post Ipo Equity· $30M
2022-09-12Post Ipo Equity· $300M

Leadership Team

leader-logo
Sanjiv Patel
President and CEO
linkedin
leader-logo
Imogen Pryce
Chief Operating Officer, R&D
linkedin
Company data provided by crunchbase