CDx Strategy & Programs Lead - Precision Medicine

BioSpace; Village of Tarrytown (NY); On-site; USD 151,000 - 246,000; Full time

Job summary

Regeneron is seeking a Senior Manager, Clinical Diagnostics to lead end-to-end CDx strategy and execution across therapeutic indications. You will translate scientific needs into fit-for-purpose assays, drive validation, and partner with biomarker, clinical, regulatory, and IVD teams to support global decisions.

Onsite in Tarrytown, NY, with up to 10% travel, you will manage IVD partners, oversee co-development, and ensure alignment with FDA, EU IVDR, and PMDA timelines while maintaining quality

Qualifications

• Advanced degree in molecular biology, pathology, biomedical engineering, or equivalent.
• 4+ years in diagnostics development, incl. 2+ years leading CDx/IVD programs.
• Proven delivery of CDx aligned with drug approvals and regulatory submissions.

Responsibilities

• Execute end-to-end CDx strategy aligned with clinical development and regulatory timelines.
• Lead cross-functional teams, integrate workstreams, and report to governance bodies and senior leadership.
• Manage IVD partners, scope, timelines, budgets, and quality across collaborations.
• Define assay intent and contribute to target product profiles for CDx platforms (NGS, PCR, IHC, immunoassays).
• Embed CDx assays in trials covering screening, stratification, and lab readiness.
• Partner with regulatory on global submissions (FDA, EU IVDR, PMDA).
• Ensure compliance with quality and regulatory frameworks (ISO 13485/14971, CLSI, IVDR, GCP).
• Thrive in fast-paced environments with strong communication for cross-functional collaboration.

Skills

Leadership

Communication

Stakeholder management

Education

Advanced degree in life sciences

Tools

NGS

PCR

IHC

Immunoassays

Job description

Regeneron is seeking a Senior Manager, Clinical Diagnostics to lead end-to-end CDx strategy and execution across therapeutic indications. You will translate scientific needs into fit-for-purpose assays, drive validation, and partner with biomarker, clinical, regulatory, and IVD teams to support global decisions.

Onsite in Tarrytown, NY, with up to 10% travel, you will manage IVD partners, oversee co-development, and ensure alignment with FDA, EU IVDR, and PMDA timelines while maintaining quality