Remote Senior Manager, CDx Strategy & Diagnostics

Regeneron Pharmaceuticals Inc.; United States; Remote; USD 151,000 - 246,000; Full time

Job summary

Regeneron Pharmaceuticals Inc. seeks a Senior Manager, Clinical Diagnostics to drive end-to-end CDx strategy and execution across therapeutic indications.

You will translate scientific needs into fit-for-purpose assays, owning programs from feasibility through validation, registration, launch, and post-market sustainment. You will lead cross-functional teams, manage IVD partners, and contribute to global regulatory submissions (FDA, EU IVDR, PMDA).

Qualifications

• PhD in molecular biology, pathology, biomedical engineering, or equivalent.
• 4+ years in diagnostics development, including 2+ years leading CDx/IVD programs.
• Proven delivery of CDx aligned to drug approvals and regulatory submissions.
• Expertise in NGS, PCR, IHC, immunoassays, and validation standards.

Responsibilities

• Execute end-to-end CDx strategy aligning milestones with clinical & regulatory timelines.
• Lead cross-functional teams, integrate workstreams, remove obstacles, and report to governance bodies.
• Manage IVD partners, negotiating scope, timelines, budgets, and quality.
• Define assay intent and contribute to target product profiles for CDx platforms.
• Embed CDx assays in trials including screening, sampling, site readiness, and lab ops.
• Partner with IVD Regulatory on global submissions (FDA, EU IVDR, PMDA).
• Ensure compliance with ISO 13485/14971, CLSI, IVDR, GCP; maintain documentation.

Skills

Leadership

Communication

Stakeholder management

Cross-functional collaboration

Education

PhD in molecular biology

PhD in pathology

PhD in biomedical engineering

equivalent

Job description

Regeneron Pharmaceuticals Inc. seeks a Senior Manager, Clinical Diagnostics to drive end-to-end CDx strategy and execution across therapeutic indications.

You will translate scientific needs into fit-for-purpose assays, owning programs from feasibility through validation, registration, launch, and post-market sustainment. You will lead cross-functional teams, manage IVD partners, and contribute to global regulatory submissions (FDA, EU IVDR, PMDA).