Senior CDx Strategy Lead – Remote

Regeneron Pharmaceuticals; United States; À distance; USD 151 000 - 246 000; Plein temps

Résumé du poste

Regeneron Pharmaceuticals is seeking 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, and launch while partnering with biomarker, clinical, regulatory, and IVD collaborators.

You will lead cross-functional teams, define assay intent for CDx platforms (NGS, PCR, IHC), and ensure alignment with

Qualifications

• PhD or equivalent in a relevant scientific field.
• 4+ years in diagnostics development, including 2+ years leading CDx/IVD programs.
• Proven delivery of CDx aligned to drug approvals and regulatory submissions.

Responsabilités

• Execute end-to-end CDx strategy aligning diagnostic milestones with clinical development and regulatory timelines.
• Lead cross-functional teams; integrate workstreams and report status to governance bodies and senior leadership.
• Manage IVD partners; negotiate scope, timelines, budgets, and quality; oversee co-development and Joint Steering Committees.

Connaissances

CDx strategy

Cross-functional leadership

Regulatory knowledge

Project leadership

Communication

Formation

PhD in molecular biology, pathology, biomedical engineering, or equivalent

Outils

NGS

PCR

IHC

Immunoassays

Description du poste

Regeneron Pharmaceuticals is seeking 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, and launch while partnering with biomarker, clinical, regulatory, and IVD collaborators.

You will lead cross-functional teams, define assay intent for CDx platforms (NGS, PCR, IHC), and ensure alignment with