Senior Director Diagnostic Assays/Cancer Biomarker Development

Job Title: Senior Director Diagnostic Assays/Cancer Biomarker Development

Location: Gaithersburg / Boston
Hybrid Working Model: 3 days per week from office 

Introduction to role:
Are you ready to lead cancer biomarker strategy that gets the right therapy to the right patient sooner and proves efficacy earlier? Do you want to shape how circulating tumor DNA and other cutting-edge assays drive decisive clinical action across a fast-moving oncology pipeline?

As Senior Director for Diagnostic Assays/Cancer Biomarker Development, you will set the vision and lead the delivery of assays that enable earlier patient identification, smarter trial designs, and faster, clearer readouts that guide development decisions. Working from our global hubs in Boston, MA or the UK, you will partner across clinical development, translational science, biostatistics, and regulatory teams to turn scientific insight into reliable, scalable diagnostic solutions that improve outcomes for people living with cancer.

Accountabilities:
- Biomarker Strategy Leadership: Define and execute strategies that use biomarkers to match patients to the right treatment and assess efficacy as early as possible, with an initial emphasis on circulating tumor DNA.
- ctDNA Innovation: Guide assay selection, validation, and deployment for minimal residual disease, response monitoring, and earlier patient identification, ensuring clinical utility and scalability.
- Clinical Trial Enablement: Design and implement biomarker-driven trial approaches that accelerate decision-making and strengthen evidence for new therapies.
- Data and Technology Influence: Provide expert advice to shape technology platforms and data analytics internally and with partners, anticipating future clinical development needs.
- Integrated Evidence Building: Combine data on new compounds and targeted disease biology to create assay strategies that de-risk programs and sharpen portfolio decisions.
- External Collaboration: Liaise with medical and technology leaders across academia, diagnostics, and industry to track advances and translate them into our trials.
- Governance and Subject Matter Expertise: Serve as the subject matter expert and governance reviewer for strategic initiatives and specific proposals.
- Regulatory Leadership: Lead regulatory communication and prepare high-level documents that support biomarker and assay use in clinical development.
- Process and Technology Modernization: Manage or support complex and groundbreaking projects to improve processes within translational science and introduce new technologies and approaches at national, regional, or global scale.
- Compliance Stewardship: Ensure your work and the function’s activities align with Good Laboratory Practice, Safety Health and Environment standards, and all relevant internal and external regulations.

Essential Skills/Experience:
- PhD or equivalent, MD or equivalent preferred
- Experience of the development and application of circulating tumor DNA assays for clinical use
- 5+ years of experience in aligned to the drug development or process in industry or academia or equivalent
- Extensive experience of crafting and implementing clinical trials using novel biomarker approaches for the earlier identification of patients
- Well-developed understanding of biomarker analysis
- Experience of communicating complex science to a clinical audience including external professional and regulatory bodies
- Proven experience managing and designing clinical trials

Desirable Skills/Experience:
- Leadership of cross-functional, global teams delivering biomarker strategies from concept to clinical deployment
- Experience shaping and submitting regulatory documentation for diagnostics, companion diagnostics, and IVDs
- Expertise in bioinformatics and analytical pipelines for ctDNA, including variant calling and minimal residual disease monitoring
- Familiarity with assay validation and operational frameworks such as CAP, CLIA, and IVDR
- Track record of high-impact publications, patents, or conference presentations in oncology biomarkers and clinical diagnostics
- Experience building external partnerships with diagnostic companies, contract research organizations, and leading academic centers
- Proven ability to drive assay adoption across multi-center clinical trials with robust sample logistics and data integrity
- Portfolio, budget, and vendor management experience for translational biomarker programs

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge percep