Diagnostics AI Project Lead

In this role you will lead the development of sequencing-based diagnostic tests for personalized cancer care. You will align test strategy with cross-functional teams and external partners to shape when testing moves in-house. Based on UK/US regulations and clinical needs, you’ll drive a unified development timeline and ensure results inform clinical decisions. This is an on-site, high-impact position designed to scale the program and improve diagnostic quality.

• 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

• Hands-on experience developing or validating sequencing-based diagnostic assays (LDTs, IVDs, or clinical research assays)
• 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

• High ownership and collaborative communication
• Cross-functional teamwork
• Strategic thinking and risk management
• Sequencing-based diagnostic assays
• LDTs and IVDs
• Analytical validation in regulated settings