Associate Director – Precision Medicine, Clinical Diagnostics

Regeneron

. Lead companion diagnostic strategy and development from early biomarker feasibility through clinical validation, regulatory submission, and launch .

Posted 10/14/2026full-timeRemote • United StatesSenior💰 $176,100 - $287,300 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading companion diagnostic strategy and development, with a strong focus on biomarker feasibility, clinical validation, and regulatory submissions. Proficient in managing cross-functional teams and external partners while ensuring compliance with relevant standards and regulatory pathways.

Highest-signal resume keywords

Companion Diagnostic StrategyBiomarker DevelopmentRegulatory SubmissionsIVD Development ManagementCross-Functional Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Biomarker FeasibilityClinical ValidationNGSPCRImmunohistochemistryImmunoassayAssay DevelopmentRegulatory ComplianceQuality Management SystemsTranslational Research

Soft Skills

CommunicationCollaborationLeadershipStrategic PlanningProblem Solving

Certifications & Qualifications

PhDAdvanced Degree in Molecular BiologyBiomedical Engineering

Industry Keywords

FDA PMAEU IVDRPMDAISO 13485ISO 14971CLSIGCPDiagnosticsTranslational ScienceBiomarker-Driven Programs

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead companion diagnostic strategy and development from early biomarker feasibility through clinical validation, regulatory submission, and launch
Translate biomarker and mechanism-of-action data into diagnostic target product profiles and define assay intent across NGS, PCR, immunohistochemistry, and immunoassay platforms
Partner with translational and clinical teams on biomarker strategies for patient selection, stratification, and enrichment, including sample strategy and specimen logistics
Lead analytical and clinical validation planning, including accuracy, precision, sensitivity/specificity, limit of detection, and reproducibility
Set global CDx strategy and align diagnostic milestones with clinical and regulatory timelines
Select and oversee IVD development partners and manage co-development scope, timelines, and quality expectations
Support global regulatory strategy and submissions, including FDA PMA/supplement, EU IVDR, and PMDA, with IVD Regulatory
Ensure compliance with ISO 13485, ISO 14971, CLSI, IVDR, and GCP-alignment standards
Lead cross-functional working groups and translate scientific rationale into program plans and governance reporting
Support design transfer, manufacturing readiness, and launch preparation with commercial and medical affairs

Requirements

What you’ll need

PhD or advanced degree in molecular biology, pathology, biomedical engineering, or a related translational/biomedical science field
8+ years in diagnostics or translational research
4+ years leading biomarker-driven CDx or IVD programs bridging bench discovery and clinical application
Track record translating biomarker science into validated assays supporting drug approvals
Working knowledge of global CDx regulatory pathways, including FDA CDRH, EU IVDR, and PMDA
Ability to translate complex scientific and clinical data for cross-functional and executive audiences
Experience managing external partners and multi-workstream programs under QMS/GxP-adjacent conditions

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 for applicants with known disabilities or chronic illnesses