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 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.
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 patients—and your career—deserve!
Closing Date 26-Nov-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
