Director, Diagnostics

AstraZeneca
Boston
Workplace: HybridFull timeUSD 180,740.8 - 271,111.2 annuallyFunction: Executive & General ManagementExperience: 10+ yearsEducation: phdSkills: ["Cross-functional leadership","Stakeholder management","Communication","Risk management","Delivery mindset"]

Lead the Diagnostics Center of Excellence strategy across the rare disease portfolio, defining end-to-end diagnostic approaches from discovery and early clinical through registration, launch, and lifecycle management. Own clinical trial diagnostic strategies and companion diagnostic co-development, ensuring analytical/clinical validation rigor and robust biomarker and endpoint plans. Partner with regulatory and diagnostic experts to deliver timely global submissions, build governance and operating models, and manage budgets and external partnerships to accelerate time to diagnosis and regulatory readiness.

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FursaFursa
AstraZeneca
AstraZeneca
2 days ago

Director, Diagnostics

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Last checked: 11 hours agoStatus: Live

Job Summary

Lead the Diagnostics Center of Excellence strategy across the rare disease portfolio, defining end-to-end diagnostic approaches from discovery and early clinical through registration, launch, and lifecycle management. Own clinical trial diagnostic strategies and companion diagnostic co-development, ensuring analytical/clinical validation rigor and robust biomarker and endpoint plans. Partner with regulatory and diagnostic experts to deliver timely global submissions, build governance and operating models, and manage budgets and external partnerships to accelerate time to diagnosis and regulatory readiness.
Location: Boston
Workplace: Hybrid
Employment Type: Full time
Job Function: Executive & General Management
Seniority: Director level

Key Responsibilities

  • •Define disease-specific diagnostic strategies for the rare disease portfolio, prioritizing for trial readiness while building a long-term precision medicine platform.
  • •Own trial-level diagnostic strategy (assays, algorithms, inclusion criteria) and lead CDx development to meet enrollment and co-submission milestones.
  • •Partner to deliver high-quality global regulatory submissions (FDA IDE/PMA; EU IVDR CPS and performance dossiers) and sustain compliance under design control.
  • •Integrate biomarker and endpoint plans by translating hypotheses into fit-for-purpose biomarkers and robust analytical/clinical validation.
  • •Manage diagnostic partners and governance/operating model elements (processes, standards, dashboards), optimizing budgets and resources across timelines, risks, and outcomes.

Pay and Benefits

Salary: USD 180,740.8 - 271,111.2 annually
Equity and Bonus:Equity
Perks:Health InsuranceDentalVisionPaid Leave401k

Key Requirements

  • •PhD (or equivalent) in a relevant scientific field, with 10+ years in precision medicine/diagnostics across discovery to launch in pharma/biotech.
  • •Proven leadership of diagnostic strategy and execution for clinical programs, including CDx development and PMA approval with diagnostic partners.
  • •Hands-on experience with global regulatory pathways (FDA IDE/PMA and EU IVDR CPS/performance requirements) plus design control and quality system expectations.
  • •Expertise in biomarker validation (analytical/clinical) and IVD development across modalities (e.g., genomics, proteomics, metabolomics; immunoassays; NGS).
  • •Strong cross-functional leadership, communication, and stakeholder management across discovery, clinical development, regulatory, commercial, and medical affairs.
Experience:10+ yearsRare diseasePrecision medicineDiagnosticsPharmaBiotech
Education:PhD / Doctorate
Skills:Cross-functional leadershipStakeholder managementCommunicationRisk managementDelivery mindset
Tech Stack:IVDCDxFDA IDEFDA PMAEU IVDRCPSNGSGenomicsProteomicsMetabolomicsImmunoassaysDesign controlAnalytical validationClinical validationBiomarkersMulti-omicsDigital pathologyImaging biomarkersReal-world data

Company Brief

AstraZeneca
Global biopharmaceutical company discovering, developing and commercializing prescription medicines across oncology, cardiovascular, renal & metabolism, respiratory, and immunology, focused on innovative therapies and vaccines to improve patient outcomes worldwide.
Industry: Pharmaceuticals
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Cambridge, United Kingdom
Founded: 1999
Glassdoor
Glassdoor: 3.8
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