Director, Diagnostics United States of America Drug Discovery Research Posted 21 hours ago

Introduction to role:

Are you ready to redefine how patients with rare diseases are found, diagnosed, and enrolled-accelerating life-changing medicines to those who need them most? As Director, Diagnostics, you will lead the Diagnostics Center of Excellence strategy across our rare disease portfolio, shaping end-to-end diagnostic approaches from late discovery and early clinical through registration, launch, and lifecycle management.

Do you thrive at the intersection of translational science, IVD development, and global regulation? You will own clinical trial diagnostic strategy, drive companion diagnostic co-development, and build the capabilities and partnerships that shorten the diagnostic odyssey and enable precision medicine r work will directly influence speed of enrollment, data quality, and regulatory readiness-turning scientific insight into measurable impact for patients and the business.

• 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 to deliver near-term trial readiness while setting the long-term platform for precision medicine growth.
• 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 that enable first-in-class and best-in-class approvals.
• 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 to de-risk launches.
• 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 to support decision-making, labeling, and clinical utility claims.
• 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 to scale access and adoption.
• External Partnerships:
  Identify, select, and manage diagnostic partners; negotiate scope, budgets, and deliverables; set success metrics and mitigation plans that keep programs on track and value-focused.
• 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 for fast, quality decisions.
• Budget and Resource Management:
  Secure budgets, optimize internal and vendor resourcing, and maintain visibility of timelines, risks, and outcomes to maximize return on investment across the portfolio.
• 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, ensuring sustained competitive advantage.

• 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.

• 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…