Diagnostics Project Lead

Apsida Life Science are currently partnered with a highly innovative, stealth-mode biotechnology company developing personalised cancer vaccines. Having recently raised $40M in seed funding, the organisation is seeking a Diagnostics Project Lead to join its growing team in London or San Francisco.This is a highly scientific and technically driven position, responsible for leading the development and validation of advanced sequencing-based diagnostic assays to support personalised cancer vaccine development. The role will involve managing an external genomics laboratory partner, collaborating closely with Clinical, Bioinformatics and Vaccine Development teams, and helping shape the organisation's future in-house sequencing capabilities.

Responsibilities

Lead the development and analytical validation of advanced sequencing-based diagnostic assays, including ultra-deep, single-cell and long-read sequencing.Translate clinical and vaccine development requirements into diagnostic assay specifications, including sequencing depth, sample types and turnaround times.Manage the technical relationship with an external genomics laboratory partner, overseeing project scope, timelines, quality and data delivery.Develop and execute assay development and validation plans, from initial feasibility through to clinical implementation.Collaborate closely with Bioinformatics, Clinical and Vaccine Development teams to ensure diagnostic data meets scientific and clinical requirements.Support regulatory and quality strategies for laboratory-developed tests (LDTs), including CLIA/CAP, FDA and UK regulatory requirements where applicable.Coordinate cross-functional stakeholders to ensure successful delivery of multiple diagnostic development programmes.Develop the strategy and business case for establishing and scaling in-house sequencing capabilities.

Requirements

PhD in Molecular Biology, Genomics or a related scientific discipline, or equivalent industry experience.Strong hands-on experience developing and validating sequencing-based diagnostic assays, including LDTs, IVDs or clinical research assays.Demonstrable experience in assay development, beyond routine sequencing or laboratory operations.Strong technical understanding of next-generation sequencing (NGS) technologies and associated analytical validation processes.Experience leading complex scientific projects and coordinating external laboratory partners or CROs.Experience with ultra-deep sequencing, liquid biopsy, ctDNA, single-cell sequencing or long-read sequencing would be highly advantageous.Previous experience taking LDTs through analytical validation within a CLIA/CAP laboratory would be beneficial.Background in oncology, molecular diagnostics or companion diagnostics is desirable.Excellent cross-functional communication, technical project management and stakeholder engagement skills.Based in London or the San Francisco Bay Area, or willing to relocate, with eligibility to work in the UK or US.

Location: London, UK or San Francisco Bay Area, USA.If you are interested in learning more, please reach out to Geneva Jones at Apsida Life Science:Geneva.jones@apsida.comwww.apsida.co.ukUS Direct: +1-617-862-3409UK Direct: +44(0)7441341762Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK) & Boston (USA) that is dedicated to delivering the best talent to the Life Science industry.

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