Director, Diagnostics

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. 

Key Responsibilities 

• 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. 

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 devel