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.
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Translational Medicine Operations Lead in Cambridge employer: T-Therapeutics Ltd
T-Therapeutics is an exceptional employer, offering a dynamic work environment that fosters creativity and collaboration among its talented team. Located in the vibrant ecosystem of Cambridge, employees benefit from access to cutting-edge research and development opportunities, as well as a strong emphasis on professional growth and mentorship. With a commitment to developing transformative medicines, T-Therapeutics provides a meaningful and rewarding career path for those passionate about making a difference in the field of biopharmaceuticals.
