Manager, Clinical Supply Chain at Relay Therapeutics

Cambridge, Massachusetts, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

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
Preferred Qualifications
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 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 & quote 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

Skills

Key technologies and capabilities for this role

supply chain managementclinical trialsIMP managementinventory managementimport/export coordinationregulatory compliancecGMPFDA regulationsEU regulationspackaging/labelingtemperature excursion managementaudit documentationvendor management

Questions & Answers

Common questions about this position

What education and experience are required for this role?

A BS/BA or equivalent in operations, life sciences, or a health-related field is required, along with a minimum of 3 years of experience in the pharmaceutical/biotechnology industry focused on clinical supply chain or clinical trial material management. Experience with primary and secondary packaging, labeling, distribution, recall processes, and regulatory requirements for clinical trial materials is also needed.

What key skills are needed for the Manager, Clinical Supply Chain position?

The role requires strong analytical, organizational, and communication skills, the ability to manage multiple tasks in a dynamic environment, a strong understanding of cGMPs, FDA, and EU regulations, and experience managing CMO contracts and vendor relationships.

Is this a remote position or does it require office presence?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

What makes a strong candidate for this clinical supply chain manager role?

Strong candidates will have at least 3 years of direct experience in clinical supply chain or trial material management in pharma/biotech, hands-on knowledge of packaging, labeling, distribution, and regulatory compliance, plus proven skills in vendor management and cross-functional collaboration.

Relay Therapeutics

Biotech company focused on drug discovery

About Relay Therapeutics

Relay Therapeutics focuses on drug discovery by studying protein motion to develop new treatments for complex diseases. Their main tool, the Dynamo™ platform, uses both experimental and computational methods to identify potential drug candidates, especially for conditions that are hard to treat with current therapies. This platform allows them to target proteins that have previously been difficult to address, particularly in areas like precision oncology and genetic diseases. Unlike many competitors, Relay Therapeutics emphasizes the importance of protein dynamics in their research, which sets them apart in the biotech field. Their goal is to create effective medicines that can significantly improve patients' lives, and they are actively conducting clinical trials to ensure the safety and effectiveness of their drug candidates.

Cambridge, MassachusettsHeadquarters

2016Year Founded

$535MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Benefits

Medical, dental, vision

Life, disability, & FSA

401k

Commuter benefits

Parental leave

Home office stipend

Tuition reimbursement

PTO

Risks

Increased competition from VantAI threatens Relay's market position.

Layoffs may impact Relay's operational efficiency and research progress.

Reliance on public offerings suggests potential financial instability for Relay.

Differentiation

Relay's Dynamo platform targets previously undruggable proteins, expanding treatment possibilities.

Focus on protein motion places Relay at the forefront of innovative drug discovery.

Relay's precision oncology approach tailors treatments to individual genetic profiles.

Upsides

AI-driven drug discovery complements Relay's computational techniques, enhancing drug development.

Quantum computing integration could boost Dynamo's capabilities in drug discovery.

Rising personalized medicine trend aligns with Relay's precision medicine focus.

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