Director, Diagnostics

Introduction to role

Lead the Diagnostics Center of Excellence strategy across the rare disease portfolio, shaping end-to-end diagnostic approaches from late discovery and early clinical through registration, launch, and lifecycle management. Own clinical trial diagnostic strategy, drive companion diagnostic co-development, and build capabilities and partnerships that shorten the diagnostic odyssey and enable precision medicine at scale.

Accountabilities

• Strategy and Portfolio Leadership: Define disease-specific diagnostic strategies grounded in deep understanding of the patient journey, clinical practice, and healthcare systems; prioritize for portfolio impact and resource allocation.
• Clinical Trial Diagnostics and CDx: Own trial-level diagnostic strategies (assays, algorithms, inclusion criteria), define and lead CDx development with diagnostic partners, and drive timelines to meet enrollment and co-submission milestones.
• Regulatory Excellence: Partner with device/diagnostic regulatory experts and external collaborators to deliver timely, high-quality global submissions (FDA IDE, PMA; EU IVDR CPS and performance dossiers; other regional requirements) and sustain compliance under design control.
• Translational Integration: Translate target and mechanism hypotheses into fit-for-purpose biomarkers and endpoints in partnership with Translational Science & Medicine; ensure analytical and clinical validation plans are robust.
• Technology and IVD SME: Serve as the subject matter expert for IVD technologies and development pathways; guide assay selection, analytical performance, clinical utility, and commercialization readiness.
• External Partnerships: Identify, select, and manage diagnostic partners; negotiate scope, budgets, and deliverables; set success metrics and mitigation plans.
• Operating Model and Governance: Establish processes, standards, and dashboards for diagnostic initiatives; ensure transparent communication and alignment with program teams, governance bodies, and senior leadership.
• Budget and Resource Management: Secure budgets, optimize internal and vendor resourcing, and maintain visibility of timelines, risks, and outcomes.
• Horizon Scanning: Maintain an up-to-date view of emerging tests, platforms, and clinical guideline changes; evolve strategies to reflect scientific, clinical, and regulatory shifts.

Essential Skills/Experience

• Advanced degree (PhD or equivalent) in a relevant scientific field
• 10+ years in precision medicine/diagnostics within pharma/biotech, spanning discovery to launch
• Proven track record leading diagnostic strategy and execution for clinical programs, including CDx development and PMA approval in partnership with diagnostic companies
• Hands-on experience with global regulatory pathways (FDA IDE/PMA; EU IVDR CPS/performance requirements), design control, and quality system expectations
• Deep expertise in biomarker validation (analytical/clinical) and IVD development; familiarity across modalities and methodologies (genomics, proteomics, metabolomics; immunoassays, biochemical assays, NGS, etc.)
• Strong portfolio thinking with the ability to translate disease biology and patient journey insights into actionable diagnostic strategies and business cases
• Exceptional cross-functional leadership, communication, and stakeholder management across discovery, clinical development, regulatory, commercial, and medical affairs
• Demonstrated success building new capabilities, processes, and partnerships; comfortable leading in ambiguity and delivering against aggressive timelines
• Experience managing external vendors/alliances and complex budgets; disciplined in risk management and governance
• Self-starter with a delivery mindset; able to both set direction and roll up sleeves as needed
• Ability to work in an office-based environment and perform essential functions with or without accommodation

Desirable Skills/Experience

• Leadership experience in rare disease diagnostics across multiple therapeutic areas and geographies
• Direct involvement in launching or commercializing IVDs or CDx in the US and EU, including post-market performance studies
• Expertise integrating multi-omics and digital pathology or imaging biomarkers into clinical development plans
• Track record of establishing scalable operational models for sample logistics, data flows, and vendor governance
• Experience engaging clinical societies, guideline bodies, and patient advocacy groups to inform diagnostic strategies
• Strong business acumen to build evidence-based business cases for diagnostic investments and market access
• Familiarity with real-world data sources to assess diagnostic performance, clinical utility, and health economics
• Proven ability to coach and develop high-performing teams and to influence at senior levels