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AstraZeneca

✓ Verified Sponsor

Director, Diagnostics

🗓️ Posted 2026-08-18 US - Boston - MA Full-time Hybrid Healthcare Medical

Company shared salary

NA

Market rate

10,000 GBP–16,667 GBP/mo (120,000 GBP–200,004 GBP/yr)

Based on similar roles (title + domain + location).

About the Company

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 at scale. Your work will directly influence speed of enrollment, data quality, and regulatory readiness-turning scientific insight into measurable impact for patients and the business. 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 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

Requirements

  • 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.
  • 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 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.
  • 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.
  • 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 perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
  • The annual base pay for this position ranges from 180,740.80 - 271,111.20. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
  • Why AstraZeneca:
  • Here you will build a unique career at the intersection of biotech agility and global scale, tackling some of the most complex challenges in rare disease. We bring diverse disciplines together to turn breakthrough science into practical diagnostics that change real patient journeys, and we back bold ideas with the resources to deliver. You will join a close-knit, mission-led community that learns fast, shares openly, and pairs ambition with kindness-so you can stretch your capabilities, shape new standards in precision medicine, and see your decisions ripple from trial design to treatment access for underserved patients.