Senior Manager, Precision Medicine – Clinical Diagnostics

Regeneron

. Execute end-to-end companion diagnostics strategy, aligning diagnostic milestones with therapeutic clinical development and regulatory timelines .

Posted 10/16/2026full-timeRemote • United StatesSenior💰 $150,500 - $245,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in executing companion diagnostics strategies, managing IVD partnerships, and ensuring compliance with regulatory standards. Proven ability to lead cross-functional teams and deliver successful CDx programs aligned with drug approvals.

Highest-signal resume keywords

PhD In Molecular BiologyDiagnostics DevelopmentCDx/IVD Program LeadershipNGS, PCR, IHC, And Immunoassays ExpertiseGlobal Regulatory Pathways Knowledge

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Applicant Tracking System Keywords

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Hard Skills

Companion Diagnostics Strategy ExecutionAnalytical And Clinical ValidationAssay Intent DefinitionRegulatory Submissions SupportQuality Systems Expertise

Soft Skills

Excellent CommunicationLeadership SkillsStakeholder Management

Tools & Technologies

IVD Partners ManagementClinical Trials IntegrationDocumentation And Audit Readiness

Industry Keywords

ISO 13485ISO 14971CLSIIVDRGCPFDA CDRHEU IVDRPMDA

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Execute end-to-end companion diagnostics strategy, aligning diagnostic milestones with therapeutic clinical development and regulatory timelines
Lead cross-functional teams, integrate workstreams, clear obstacles, and provide status reporting to governance bodies and senior leadership
Manage IVD partners, negotiating scope, timelines, budgets, and quality
Oversee co-development and Joint Steering Committees
Define assay intent and contribute to target product profiles for CDx platforms including NGS, PCR, IHC, and immunoassays
Drive analytical and clinical validation
Embed CDx assays in clinical trials, covering screening/stratification, sampling, site readiness, and lab operations
Partner with IVD Regulatory on global submissions, supporting pre-subs, labeling, and responses
Ensure compliance with ISO 13485/14971, CLSI, IVDR, and GCP frameworks
Maintain documentation and audit readiness
Collaborate across biomarker, clinical, regulatory, commercial, and IVD functions

Requirements

What you’ll need

PhD in molecular biology, pathology, biomedical engineering, or equivalent
4+ years in diagnostics development
2+ years leading CDx/IVD programs in pharma or diagnostics organizations
Proven delivery of CDx aligned to drug approvals, with successful validation and regulatory submissions
Expertise in NGS, PCR, IHC, and immunoassays
Expertise in validation standards and quality systems
Strong grasp of global regulatory pathways, including FDA CDRH, EU IVDR, and PMDA, for CDx labeling
Excellent communication, leadership, and stakeholder management skills
Ability to deliver clear updates to executive audiences

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