Translational Medicine Operations Lead

T-Therapeutics Ltd; Cambridge; Hybrid; GBP 90,000 - 130,000; Full time

Benefits offered by this job

28 days holiday

Generous pension contribution

Life insurance

Health insurance

Health cash plan

Job summary

T-T-Therapeutics Ltd in the UK is seeking a Translational Medicine Operations Lead to manage the biomarker lifecycle and external testing strategies across preclinical and clinical portfolios.

The role ensures ICH-GCP compliance and HTA governance for human biosamples, while leading biobank development, SOPs, and LIMS data traceability across global sites.

Qualifications

• Degree-level qualification in Life Sciences, Molecular Biology, Biochemistry, or related field.
• Minimum 5+ years hands-on experience in clinical trial operations, preclinical translational research, or biomarker sample management.
• Proven track record of independently managing external CROs and complex sample vendor networks in a GCP-regulated environment.

Responsibilities

• Oversee end-to-end translational medicine operations in preclinical and clinical portfolios.
• Lead biorepository setup, SOPs, and data traceability systems (LIMS) including MTAs and vendor contracts.
• Manage CRO vendor onboarding, SOWs, budgets, and performance KPIs to ensure timely, compliant biomarker data delivery.
• Ensure strict ICH-GCP and HTA compliance across workflows and audit readiness.

Skills

ICH-GCP

HTA Standards

Leadership

Budget management

Cross-functional teamwork

Education

Bachelor’s/Master’s/PhD in Life Sciences or related

Tools

LIMS

MTAs

Job description

T-Therapeutics is a next-generation T cell receptor (TCR) T cell engager (TCE) company developing novel therapeutics. The company harnesses T cell biology to create safe and effective treatments for cancer and autoimmune disease. The company is developing a pipeline of first-in-class drugs that are intended to become transformative medicines, reshaping the clinical landscape for patients with cancer or autoimmune diseases.

A venture backed company, T-Therapeutics’ experienced team combines world-leading expertise in biopharmaceutical drug development anchored in a culture of creativity and collaboration.

About the Opportunity

The Translational Medicine Operations Lead will provide end-to-end operational management for the human biosample lifecycle and external testing strategies across both our preclinical and clinical trial portfolios. This dual-responsibility role bridges the gap between early-stage discovery and clinical execution. The successful candidate will ensure full compliance with ICH-GCP guidelines for clinical studies, while strictly governing the procurement, storage, and bench-use of "relevant material" under Human Tissue Authority (HTA) standards in the preclinical space.

In this role, the Translational Medicine Operations Lead will be responsible for:

Preclinical and Clinical Biomarker Study Execution

• Operationalise biomarker strategies across discovery, preclinical pipelines, and active clinical trial portfolios.
• Author, review, and refine biomarker sections of clinical trial protocols, site lab manuals, and Informed Consent Forms (ICFs).
• Integrate biosampling workflows seamlessly into preclinical in vitro/in vivo validation plans and clinical study designs.

Biorepository and Sample Sourcing Operations

• Lead the administrative establishment of the new in-house biobank, including the coordination of infrastructure layout, procurement of specialised equipment, and vendor contract management.
• Develop and implement foundational Standard Operating Procedures (SOPs), quality management workflows, and a Laboratory Information Management System (LIMS) to ensure complete data traceability from inception.
• Oversee global sourcing of high-quality human biological samples in strict accordance with ethical consents, Material Transfer Agreements (MTAs), and regional laws.
• Manage complex tracking and chain of custody for patient samples across global investigator sites, central labs, and biorepositories.
• Mitigate operational risks related to sample collection, stability, processing, and long-distance cold-chain logistics.

CRO and Vendor Outsourcing Management

• Drive the vendor pipeline by identifying, qualifying, auditing, and onboarding specialised biomarker testing CROs and central laboratories.
• Negotiate work orders, complex Scopes of Work (SOWs), and clinical study biomarker budgets to maximise cost-efficiencies.
• Govern CRO performance using strict KPIs to guarantee high-quality biomarker data delivery within study timelines.

Regulatory Compliance, GCP, and HTA Oversight

• Enforce strict compliance with ICH-GCP guidelines and the Human Tissue Act (2004) across all translational workflows.
• Govern preclinical storage and use of human tissues, fluids, and primary cells, ensuring strict alignment with corporate HTA licences or REC exemptions.
• Maintain inspection readiness for all biomarker operational documentation, sample tracking records, and vendor oversight files.
• Lead audit remediations and process improvements to resolve any clinical biomarker testing or preclinical sampling deviations.

About you

Education and Experience

• Degree-level qualification (Bachelor’s, Master’s, or PhD) in Life Sciences, Molecular Biology, Biochemistry, or a highly related discipline.
• Minimum 5+ years of hands‑on experience in clinical trial operations, preclinical translational research, or biomarker sample management.
• Proven track record of independently managing external CROs and complex sample vendor networks, particularly in a clinical trial GCP regulatory environment.

Skills and Competencies

• Expert knowledge of ICH-GCP and HTA Standards for the procurement, storage, export, and disposal of human biosamples.
• Strong cross-functional leadership with the capability to translate scientific goals from discovery scientists into clear execution plans for clinical study teams.
• Excellent budget management and commercial contract negotiation skills for vendor agreements.
• Thrives in a fast-paced environment with the agility to manage shifting priorities across multiple drug development programmes.
• Job Title: Translational Medicine Operations Lead.
• Location: Great Abington, UK with potential flexible working scheme.
• Employment Type: Full-time, Permanent.

Company Benefits

T-Therapeutics offers employees a wide range of benefits. These include 28 days' holiday (excluding bank holidays), a generous pension contribution, life insurance, health insurance, and a health cash plan.

You will have the opportunity to contribute to innovative drug development, in an open environment, able to learn all aspects of drug development. T-Therapeutics is also committed to enabling staff to grow professionally in a variety of ways as well as providing the chance to develop cutting-edge technologies.