Senior Manager, Clinical Diagnostics CDx – Precision Medicine

Regeneron

Senior Manager, Clinical Diagnostics at Regeneron managing global CDx strategy and execution across therapeutic indications. Leading cross-functional teams and ensuring compliance with regulatory standards.

Posted 6/11/2026full-timeTarrytown • New York • 🇺🇸 United StatesSenior💰 $150,500 - $245,500 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Support end-to-end CDx strategy and execution to enable therapeutics across indications.
Partner with biomarker, clinical, regulatory, commercial, and IVD collaborators.
Own programs from feasibility through analytical/clinical validation, registration, launch, and post-market sustainment.
Manage IVD partners—negotiating scope, timelines, budgets, and quality.
Embed CDx assays in trials with clinical teams for reliable execution.
Ensure compliance with ISO 13485/14971, CLSI, IVDR, and GCP; maintain documentation and audit readiness.

Requirements

What you’ll need

Advanced degree in molecular biology, pathology, biomedical engineering, or equivalent experience.
4+ years in diagnostics development; 2+ years leading CDx/IVD in pharma or diagnostics organizations.
Proven delivery of CDx aligned to drug approvals; successful validation and regulatory submissions.
Expertise in NGS, PCR, IHC, immunoassays; validation standards and robust quality systems.
Strong grasp of global FDA CDRH, EU IVDR, PMDA pathways for CDx labeling.

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
insurance benefits (e.g. medical, dental, vision, life and disability)
paid time off
family support benefits

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

molecular biologypathologybiomedical engineeringdiagnostics developmentCDxIVDNGSPCRIHCimmunoassays

Soft Skills

negotiationproject managementcollaborationcommunicationleadership