Director, Diagnostics

Introduction to role:

Are you ready to redefine how patients with rare diseases are found diagnosed and enrolledaccelerating 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 readinessturning 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 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.

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.

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were 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 $ 180740.80 - $271111.20. Our positions offer eligibility for various incentivesan 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 kindnessso 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.

Call to Action:

If you are ready to own the diagnostics strategy that shortens time to diagnosis and accelerates transformative therapies step in and lead the change that patientsand your careerdeserve!