Description
Role Summary
Lead the Diagnostics Centre 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.
Key Responsibilities
Strategy and Portfolio Leadership:
Define disease-specific diagnostic strategies grounded in deep understanding of patient diagnostic journeys, clinical practice, and healthcare systems; prioritise 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 commercialisation 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, optimise 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.
Qualifications
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.