Director Diagnostics

Are you ready to lead the charge in redefining diagnostic strategies? As the Director of Diagnostics, you'll spearhead the Diagnostics Center of Excellence (DxCoE) strategy, driving innovation from late discovery through clinical development, registration, launch, and lifecycle management. Your mission is to craft end-to-end diagnostic approaches that accelerate precision medicine at scale. You'll lead the clinical trial diagnostic strategy, ensuring swift patient enrollment, high-quality data, and regulatory readiness. Join us in building capabilities, processes, and partnerships that shorten the diagnostic odyssey and redefine patient care.

Accountabilities

Strategy and Portfolio Leadership: Define disease-specific diagnostic strategies based on a understanding of patient journeys, clinical practice, and healthcare systems. Prioritize portfolio impact and resource allocation to improve outcomes.

Clinical Trial Diagnostics and CDx: Lead trial-level diagnostic strategies, including assays, algorithms, inclusion criteria, CDx definition and development. Drive timelines to meet enrollment and submission timelines for co-approval of drug and CDx.

Regulatory Excellence: Collaborate with internal device/diagnostic regulatory teams and external partners to deliver global submissions and maintain compliance under design control.

Translational Integration: Work with Translational Science & Medicine to translate disease hypotheses into biomarkers and clinical endpoints. Ensure robust analytical and clinical validation plans.

Technology and IVD SME: Serve as a subject matter expert for IVD technologies, guiding assay selection, analytical performance, clinical utility, and commercialization readiness.

External Partnerships: Identify and lead partners, negotiate scope, budgets, and deliverables. Lead all aspects of execution with success metrics and risk mitigation.

Operating Model and Governance: Establish processes, standards, and dashboards for diagnostic initiatives. Ensure timely communication and alignment with program teams and senior leadership.

Budget and Resource Management: Secure budgets, optimize vendor and internal resourcing, maintain clarity on timelines, risks, and outcomes.

Horizon Scanning: Stay informed on emerging tests, platforms, and guideline updates. Evolve strategies to reflect scientific, clinical, and regulatory changes.

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.
• Consistent 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 cases.
• Outstanding cross-functional leadership, communication, and collaborator 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 bold timelines.
• Experience leading external vendors/alliances and complex budgets; well-adapted in risk management and governance.

At AstraZeneca's Alexion division, you'll find a unique blend of entrepreneurial spirit within a leading biotech supported by the resources of a global pharma. Our commitment to patients living with rare diseases drives us to innovate continuously. Here, you'll be part of an energizing culture where connections are built to explore new ideas. With tailored development programs designed for skill enhancement and fostering empathy for patient journeys, you'll be empowered to make a real impact. Join us in a community that celebrates diversity, innovation, and the power of connection.

Ready to redefine diagnostics for rare diseases? Apply now to join our team!

Date Posted

Closing Date

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.