Mission
Director,Diagnostics
Neural analysis suggests this role is
optimal for Director candidates.
“Director, Diagnostics at Mission. Skills: Diagnostics strategy, Companion Diagnostics, Regulatory excellence, Biomarker validation. Define diagnostic strategies. Prioritize portfolio impact”
What You'll Achieve.
Shorten diagnostic odyssey; Enable precision medicine; Meet enrollment milestones; Meet submission milestones; Deliver global submissions; Sustain compliance; Ensure robust validation plans
Industry & Context.
Risk mitigation
What They're Looking For.
Must Have
Advanced degree (PhD or equivalent), 10+ years in precision medicine/diagnostics, Proven track record leading diagnostic strategy, Hands-on experience with global regulatory pathways, Deep expertise in biomarker validation, Portfolio thinking, Exceptional cross-functional leadership, Demonstrated success building new capabilities, Experience managing external vendors/alliances, Ability to work in an office-based environment
Nice to Have
PMA approval in partnership with diagnostic companies, EU IVDR CPS/performance requirements, Comfortable leading in ambiguity, Disciplined in risk management and governance
What You'll Do.
Define diagnostic strategies
Prioritize portfolio impact
Lead trial-level diagnostic strategies
Deliver global submissions
Ensure validation plans
Guide assay selection
Identify external partnerships
Manage external partnerships
Ensure timely communication
Maintain transparency
Maintain up-to-date view
How You'll Work.
Team & Collaboration
Cross-functional leadership; Program teams; Governance bodies; Senior leadership
Communication Scope
Communication; Stakeholder management
Process & Methodology
Resource management, Timeline management, Risk management
Full Job Description
_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
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