Diagnostics AI Project Lead

Overview Lead the development of advanced sequencing-based diagnostic tests that support personalized cancer care.
You'll shape test strategy, guide external development, and help determine when testing should move in-house.
This is an on-site opportunity for an experienced assay development scientist ready to own a high-impact, cross-functional program.
Your work will influence clinical decision-making, diagnostic quality, and the future scalability of the program.
About our client Our client is a life sciences organization focused on personalized cancer treatment. Its work uses detailed information about tumors and immune systems to support individualized therapeutic decisions. This role is central to building the diagnostic capabilities that enable that mission.
The opportunity (Role summary) As Diagnostics AI Project Lead, you will translate clinical and therapeutic needs into clear diagnostic test specifications, including assay design, sample type, sequencing depth, and turnaround time. You will manage the day-to-day relationship with an external laboratory partner, coordinate internal scientific and technical stakeholders, and maintain one integrated development timeline.
This is an on-site role based in London or the San Francisco Bay Area. Candidates must be authorized to work in the UK or US, or have a realistic path to obtain authorization.
Key responsibilities Lead development and validation plans for laboratory-developed tests from feasibility through clinical use.
Manage external laboratory scope, timelines, data handoffs, quality, and turnaround.
Partner with clinical, therapeutic, bioinformatics, regulatory, and quality teams.
Translate clinical requirements into practical assay and test specifications.
Ensure sequencing data is returned in a format suitable for downstream analysis.
Analyze regulatory pathways, including applicable laboratory, US, and UK requirements.
Build the strategy and business case for bringing testing capabilities in-house.
Maintain a unified program timeline across multiple stakeholders.

What you'll bring Hands-on experience developing or validating sequencing-based diagnostic assays, including LDTs, IVDs, or clinical research assays.
A PhD in molecular biology, genomics, or a related field, or equivalent industry experience.
Experience managing a sequencing service provider or CRO as a technical partner.
Ability to manage complex, multi-party programs with high ownership and collaborative communication.
Experience with analytical validation in a regulated laboratory environment.
Knowledge of ultra-deep or low-input sequencing, liquid biopsy, circulating tumor DNA, deep panels, molecular error suppression, single-cell assays, or long-read sequencing.
Oncology or companion diagnostics experience.
Some knowledge of relevant laboratory and medical-device regulations.