Principal ​/ Senior Scientist, Translational Research - Clinical Assays and Companion Diagnostics

At Lab Genius Therapeutics ( Lab Genius ), our mission is to discover the next generation of therapeutic antibodies by combining human and machine intelligence. To do this, we’ve pioneered the development of EVA™, state-of-the‑art automated platform, enabling the closed-loop discovery of high-performing, non‑intuitive antibody designs using proprietary, ML-grade datasets. For our wholly‑owned therapeutic pipeline, we’re using our closed‑loop discovery engine to establish a pipeline of highly selective T‑cell engagers and ADCs for the treatment of solid tumours.

Lab Genius has raised >£55M and is backed by top‑tier investors, including M Ventures, Octopus Ventures, LG Corp, Atomico, Kindred Capital, Lux Capital and Obvious Ventures amongst others. The company is headquartered in London (UK) where we’ve established a cutting‑edge antibody engineering facility. The company is staffed by a multidisciplinary team of more than 50 scientists and engineers.

An experienced Translational Scientist with a strong background in clinical immunology to lead the clinical translation strategy for our advancing pipeline. This role focuses on the development, validation, and clinical implementation of biomarker and clinical PK/PD assays, as well as driving Companion Diagnostic (CDx) or patient‑stratification strategies. You will oversee the transition of assays into clinical‑grade tests, managing the internal technical transfer of mature assays from preclinical groups and directing the external tech transfer and scale‑up to clinical CROs, reference labs, and central laboratories globally.

• Clinical Assay Development: Oversee the development, optimization, and validation of robust clinical assays to measure T‑cell engagement, peripheral B‑cell/target‑cell depletion, and soluble biomarkers (e.g., cytokine release panels, inflammatory markers).

• Vendor & Outsource Management: Audit, select, and manage relationships with specialized clinical CROs and diagnostic vendors, ensuring all transferred assays meet strict GxP and regulatory standards (FDA, IVDR, CLIA/CAP).

• Internal Clinical Tech Transfers: Partner with internal preclinical translational and discovery biology groups to pull mature, validated biomarker assays into the clinical translation workflow. Evaluate and adapt these assays to ensure they are fit for clinical compliance.

• External Clinical CRO Tech Transfers: Direct and manage the formal technical transfer of validated biomarker, PK/PD, and receptor occupancy (RO) assays from internal R&D to global clinical CROs, reference labs, and diagnostic partners. Ensure successful assay qualification, validation, and cross‑validation across multiple global testing sites.

• CDx & Stratification Strategy: Lead the development of Companion Diagnostics and clinical biomarker strategies tailored for IO and autoimmune therapies. Identify patient selection biomarkers (e.g., quantitative target expression, HLA typing, autoantibody profiles, baseline immune cell subset ratios) and drive CDx development through regulatory approval.

• Regulatory Report Writing & Review: Author and critically review assay validation plans, qualification reports, data transfer agreements (DTAs), and the biomarker/diagnostic sections of clinical protocols, Investigator Brochures (IBs), and regulatory filing documents (e.g., IND, NDA, PMA).

• Education: PhD in Immunology, Oncology, Molecular Diagnostics, or a related field with robust clinical translational experience in the biopharma industry.

• Bi-directional Tech Transfer Expertise: Proven success in pulling assays from internal groups and executing formal, documented assay tech transfers to external clinical CROs, including defining acceptance…