Medical Director, Companion Diagnostics and Advanced Assays

Location: Newcastle Upon Tyne, United Kingdom; hybrid on-site/remote. The role involves 30–40% international travel.

Company

hirify.global, a Danaher operating company, develops cancer diagnostic solutions spanning biopsy to diagnosis and supports precision medicine and pharmaceutical partnerships.

What you will do

• Provide medical and clinical leadership for advanced assay, companion diagnostic, and pharmaceutical partnership programs.
• Direct clinical studies, R&D projects, and regulatory submissions as the medical subject-matter expert.
• Build clinical evidence and support pharma partnerships, strategic growth, and adoption of advanced diagnostic technologies.
• Define assay design specifications, IVD and CDx study plans, training materials, and interpretation guides.
• Contribute to regulatory strategy, meetings with regulators including the FDA, and review of promotional materials.
• Provide pathology input to device risk analyses, health hazard evaluations, adverse-event reviews, and risk-benefit reporting.

Requirements

• PhD-qualified pathologist with advanced scientific training and a record of quality publications.
• FRCPath Parts 1 and 2 board certification in Histopathology.
• Full GMC registration, license to practice, and Specialist Register entry in Histopathology.
• More than two years of experience in diagnostics, laboratory, biopharma, medical device, or a related industry.
• Experience developing in vitro diagnostic products and interacting with regulatory agencies.
• Ability to travel 30–40%, including internationally.

Nice to have

• Training in molecular genetic pathology, hematopathology, clinical informatics, or organ-specific histopathology such as GI, GU, or breast.
• Experience in computational pathology, clinical informatics, machine learning, and artificial intelligence applied to digital pathology.
• Experience with medical-device or biopharmaceutical risk management, safety assessment, product development, or business development.
• Experience influencing multidisciplinary teams, managing multiple projects, and building relationships across functions.

Culture & Benefits

• Benefits include healthcare programs and paid time off.
• Flexible remote working arrangements are available for eligible roles, including remote work from home for this position.
• Work in a global, collaborative, matrixed organization focused on cancer diagnostics and life sciences innovation.
• Use the Danaher Business System to support continuous improvement and operational impact.