Senior Director, Clinical Diagnostics – Precision Medicine

Regeneron

. Set and lead global companion diagnostics strategy across the entire therapeutic pipeline and all technologies .

Posted 10/13/2026full-timeRemote • New York • United StatesSenior💰 $242,000 - $403,300 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in companion diagnostics strategy, assay development, and regulatory pathways, with a strong focus on integrating diagnostic plans with clinical objectives and patient needs. Proven leadership in managing cross-functional teams and external partnerships to drive successful diagnostic outcomes.

Highest-signal resume keywords

Companion Diagnostics StrategyAssay DevelopmentGlobal CDx Regulatory PathwaysBiomarker StrategyPeople Leadership

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Applicant Tracking System Keywords

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Hard Skills

Clinical UtilityAnalytical ValidationRegulatory SubmissionBiomarker BiologyDiagnostic Target Product ProfilesPatient Selection StrategiesIVD DevelopmentTranslational MedicineFeasibility AssessmentQuality Oversight

Soft Skills

Mentoring TalentCollaborative Team EnvironmentSetting PrioritiesInfluencing DecisionsBuilding Capability

Tools & Technologies

Laboratory WorkflowsSample ManagementData TransferGovernanceContracting

Industry Keywords

FDA CDRHEU IVDRPMDAIVD SponsorsCROsPerformance StudiesPost-Approval ObligationsClinical DevelopmentTherapeutic ApprovalDiagnostics

About the role

Key responsibilities & impact

Set and lead global companion diagnostics strategy across the entire therapeutic pipeline and all technologies
Integrate diagnostic plans with clinical strategy, development objectives and timelines, regulatory requirements, launch planning, and patient identification needs
Translate biomarker biology, mechanism-of-action hypotheses, and clinical utility considerations into diagnostic target product profiles
Define assay selection and development strategy from feasibility through analytical and clinical validation, regulatory submission, and post-approval lifecycle planning
Lead diagnostic strategies supporting patient selection, stratification, monitoring, and evidence generation
Oversee external IVD sponsors, laboratory and technology partner relationships, including selection, contracting, governance, budgets, and issue escalation
Ensure operational readiness of CDx testing in clinical trials, including study startup, laboratory workflows, sample management, data transfer, and quality oversight
Shape global CDx regulatory strategy with Regulatory Affairs, including FDA, EU IVDR, PMDA, and other regional requirements
Serve as senior CDx subject matter expert and strategic advisor to program teams and leadership
Influence decisions across translational medicine, clinical development, regulatory, biostatistics, clinical operations, commercial, medical affairs, market access, quality, and legal
Lead and develop a team of diagnostic professionals

Requirements

What you’ll need

Advanced degree (PhD, MD, MD/PhD, or equivalent) in molecular biology, pathology, translational medicine, oncology, biomedical engineering, diagnostics, or a related scientific discipline
12 or more years of experience in companion diagnostics, IVD development, biomarker strategy, or translational medicine within pharma, biotech, or diagnostics
Progressive leadership responsibility
Demonstrated success leading CDx or biomarker-enabled diagnostic strategies through clinical development, regulatory submission, and therapeutic approval
Deep expertise in assay development, analytical and clinical validation, and clinical utility
Strong working knowledge of global CDx regulatory pathways, including FDA CDRH (PMA and supplemental submissions), EU IVDR, PMDA, performance studies, labeling, and post-approval obligations
Experience managing external diagnostic partners, IVD sponsors, central laboratories, CROs, and technology vendors within complex, timeline-sensitive programs
Proven people leadership, including mentoring talent, building capability, and setting priorities in a collaborative, accountable team environment

Benefits

Comp & perks

Annual bonuses or other incentive plans
Equity awards
Pension or retirement benefits
401(k) company match
Health and wellness programs
Fitness centers
Medical, dental, vision, life, and disability insurance benefits
Paid time off
Family support benefits
Reasonable accommodation during the recruitment process where required