Senior Manager, Clinical Diagnostics CDx (Precision Medicine)

Responsibilities

• Execute end-to-end CDx strategy, aligning diagnostic milestones with therapeutic clinical development and regulatory timelines.
• Lead cross-functional teams to integrate workstreams, clear obstacles, and provide status reporting to senior leadership.
• Manage IVD partners by negotiating scope, timelines, and budgets, and overseeing Joint Steering Committees.
• Define assay intent and contribute to target product profiles for platforms including NGS, PCR, IHC, and immunoassays.
• Drive analytical and clinical validation to link assay performance to benefit-risk profiles.
• Partner with IVD Regulatory teams on global submissions, including FDA PMA/510(k), EU IVDR, and PMDA.
• Ensure compliance with ISO 13485/14971, CLSI, IVDR, and GCP standards.
• Oversee design transfer, manufacturing readiness, and supply chain support for product launch.

Requirements

• Advanced degree in molecular biology, pathology, biomedical engineering, or equivalent experience.
• 4+ years of experience in diagnostics development.
• 2+ years of experience leading CDx/IVD programs within pharma or diagnostics organizations.
• Proven track record of delivering CDx aligned to drug approvals and successful regulatory submissions.
• Technical expertise in NGS, PCR, IHC, and immunoassays, including validation standards.
• Strong knowledge of global regulatory pathways, including FDA CDRH, EU IVDR, and PMDA.
• Excellent leadership, stakeholder management, and communication skills for executive audiences.

About the Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, the company focuses on translating science into medicine to treat eye diseases, cancer, cardiovascular diseases, and rare diseases. Regeneron is recognized for its culture of innovation and commitment to scientific excellence.