Director, Diagnostics

Responsibilities

• Lead the Diagnostics Center of Excellence (DxCoE) strategy and execution across the rare disease portfolio.
• Own clinical trial diagnostic strategy, including patient selection, biomarker-driven enrichment, and Companion Diagnostic (CDx) development.
• Partner with internal and external regulatory teams to deliver global submissions, including FDA IDE/PMA and EU IVDR.
• Collaborate with Translational Science & Medicine to translate disease hypotheses into fit-for-purpose biomarkers and clinical endpoints.
• Serve as a subject matter expert for IVD technologies, guiding assay selection and analytical performance.
• Identify, select, and manage external diagnostic partners, overseeing execution and risk mitigation.
• Establish processes, standards, and governance for diagnostic initiatives across program teams.

Requirements

• PhD or equivalent in a relevant scientific field.
• 10+ years of experience in precision medicine or diagnostics within the pharma/biotech industry.
• Proven track record in CDx development and leading diagnostic strategy for clinical programs.
• Hands-on experience with global regulatory pathways, specifically FDA IDE/PMA and EU IVDR.
• Deep expertise in biomarker validation (analytical and clinical) and IVD development.
• Strong cross-functional leadership skills with experience managing external vendors and complex budgets.

Benefits

• Competitive annual base pay.
• Short-term incentive bonus opportunities.
• Eligibility for equity-based long-term incentive programs.
• Qualified retirement program (401(k) plan).
• Comprehensive health benefits including medical, prescription drug, dental, and vision coverage.
• Paid vacation, holidays, and leaves.

About the Company

AstraZeneca is a global, science-led biopharmaceutical company that focuses on discovering, developing, and commercializing prescription medicines in oncology, rare diseases, and biopharmaceuticals.