At LabGenius Therapeutics ("LabGenius"), 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.

LabGenius 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.

What you’ll do in this role

• 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).

What we’re looking for

• 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 criteria and managing external validation phases.

• Regulatory & Technical Documentation: Deep understanding of regulatory frameworks governing clinical assays alongside expert proficiency in writing and reviewing clinical study documents under GLP/GCP compliance.

• Immunology Knowledge: Solid grasp of clinical IO endpoints (e.g., iRECIST) and TCE-specific clinical challenges (e.g., Cytokine Release Syndrome mitigation, target-mediated drug disposition).

• Technical Platforms: Extensive experience with clinical assay modalities including multiplex Immunohistochemistry (mIHC/spatial biology), flow cytometry panels, Companion NGS panels, and high-sensitivity immunoassay platforms.

What you’ll receive from us

Aside from being part of our brilliant, purpose-driven team, you’ll also enjoy:

Financial 💸

• Discretionary performance-linked annual bonus

• A generous stock option plan

• 3x Salary Life Insurance

• Health cash back plan on day-to-day health expenses

• Enhanced pension contribution, with an additional top up on tax savings from us via salary sacrifice

Health 🍏

• Private Medical Insurance, including dental and optical

• Discounted gym membership through either AXA or Health Shield

• 24/7 access to GP Services

• Access to the Cycle to Work scheme: to make your commute cheaper, healthier and a whole lot greener

Time-Off ⏰

• 25 days annual leave (plus the bank holidays)

• Paid sick leave and income protection for long term leave

• Paid emergency leave so it doesn’t eat into your relaxation time

• Paid bereavement leave

• Moving home day

Wellbeing 💛

• Employee Assistance Programme including access to coaching and CBT sessions

Team-building 🤝

• Weekly team lunches through Feedr.

• A programme of social events both company-wide and within your own teams

Diversity & Inclusion

We believe that diversity makes for innovative, exceptional teams.

We are an equal opportunity employer and do not discriminate based on gender, race, colour, religion or belief, national origin, age, sexual orientation, marital status, disability, or any other protected class.

If you don't feel like you meet every single requirement of this role, we still want to hear from you! We encourage you to apply, have a discussion with us about the role or others that we may have at LabGenius either now or in the future, together we can build more inclusive workplaces.