Remote Senior Director, CDx & Precision Medicine Strategy

Regeneron Pharmaceuticals Inc.; United States; Remote; USD 242,000 - 403,000; Full time

Job summary

Regeneron Pharmaceuticals Inc. seeks a Senior Director to set and drive global companion diagnostics strategies across a diverse portfolio.

You will integrate CDx plans with clinical development, regulatory submissions, and patient access goals while leading a team of diagnostic professionals. You will translate biomarker biology into target profiles across NGS, PCR, IHC and immunoassays, define assay strategies, supervise external partners, and ensure trial readiness with regulatory teams

Qualifications

• Advanced degree in molecular biology, pathology, translational medicine, oncology, biomedical engineering, diagnostics, or related field.
• 12+ years of experience in companion diagnostics or translational medicine with leadership responsibility.
• Proven success leading CDx or biomarker-enabled strategies through development and regulatory approval.
• Deep expertise in assay development, validation, and clinical utility.
• Strong knowledge of global CDx regulatory pathways (FDA/PMDA/EU IVDR) and post‑approval obligations.
• Experience managing external diagnostic partners and CROs in complex programs.

Responsibilities

• Set and lead global CDx strategy across pipelines and technologies, aligning with clinical development and regulatory plans.
• Translate biomarker biology into diagnostic target profiles across platforms (NGS, PCR, IHC, immunoassays).
• Define assay selection and development strategy from feasibility to regulatory submission and lifecycle planning.
• Lead a team to develop diagnostic strategies for patient selection, stratification, monitoring, and evidence generation.
• Provide executive oversight of external IVD sponsors, labs, and partner relationships, including budgeting and governance.
• Ensure operational readiness of CDx testing in clinical trials, including workflows and data transfer.
• Shape regulatory strategy with FDA, EU IVDR, PMDA, and other regions; oversee study design and labeling.

Skills

CDx leadership

Biomarker strategy

IVD development

Clinical development

Regulatory strategy

Education

Advanced degree (PhD/MD)

Tools

NGS

PCR

Immunohistochemistry

Immunoassays

Job description

Regeneron Pharmaceuticals Inc. seeks a Senior Director to set and drive global companion diagnostics strategies across a diverse portfolio.

You will integrate CDx plans with clinical development, regulatory submissions, and patient access goals while leading a team of diagnostic professionals. You will translate biomarker biology into target profiles across NGS, PCR, IHC and immunoassays, define assay strategies, supervise external partners, and ensure trial readiness with regulatory teams