Strategy and Portfolio Leadership: Define disease-specific diagnostic strategies grounded in deep understanding of patient diagnostic journeys, clinical practice, and healthcare systems; prioritize portfolio impact and resource allocation.
Clinical Trial Diagnostics and CDx : Lead trial-level diagnostic strategies (assays, algorithms, inclusion criteria), CDx definition and development, and readiness for co-approval of drug and CDx , drive timelines to meet enrollment and submission milestones.
Regulatory Excellence: Partner with internal device/diagnostic regulatory and external partners to deliver global submissions (FDA IDE, PMA; EU IVDR CPS and performance dossiers; other regional requirements) and sustain compliance under design control.
Translational Integration: Collaborate with Translational Science & Medicine to translate disease/target/MOA hypotheses into fit-for-purpose biomarkers and clinical endpoints; ensure analytical and clinical validation plans are robust.
Technology and IVD SME: Serve as subject matter expert for IVD technologies and development pathways; guide assay selection , analytical performance, clinical utility, and commercialization readiness.
External Partnerships: Identify , select, and manage diagnostic partners; negotiate scope, budgets, and deliverables; oversee execution with clear 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, governance bodies, and senior leadership.
Budget and Resource Management: Secure budgets, optimize vendor and internal resourcing, and maintain transparency on timelines, risks, and outcomes.
Horizon Scanning: Maintain up-to-date view of emerging tests, platforms, and guideline updates; evolve strategies to reflect scientific, clinical, and regulatory changes.
Requirements
Advanced degree (PhD or equivalent) in a relevant scientific field; 1 0 + 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.
Benefits
Health insuranceDental insuranceVision insurance401(k)Paid time offEquity / stock optionsPerformance bonus
Additional Information
Role Summary
Lead the Diagnostics Center of Excellence ( DxCoE ) strategy and execution across the rare disease portfolio, shaping end-to-end diagnostic approaches from late discovery/early clinical through development, registration, launch, and lifecycle management .
Own clinical trial diagnostic strategy , including patient selection, biomarker-driven enrichment, and Companion Diagnostic ( CDx ) development , ensuring speed of enrollment, data quality, and regulatory readiness.
Build capabilities, processes, and partnerships that shorten the diagnostic odyssey and enable precision medicine at scale.
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