Associate Director, CDx Strategy & Diagnostics (Remote)

Regeneron Pharmaceuticals, Inc.; United States; Remote; USD 180,000 - 240,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking an Associate Director to lead companion diagnostic (CDx) strategy and development across biomarker feasibility through clinical validation, regulatory submission, and launch.

You will bridge translational science with diagnostic execution and collaborate with translational, clinical, regulatory, and external IVD partners. The role requires guiding global CDx programs, coordinating cross-functional teams, and ensuring diagnostics align with therapeutic

Qualifications

• PhD or advanced degree in molecular biology, pathology, biomedical engineering, or related translational/biomedical science field.
• 8+ years in diagnostics or translational research, with 4+ years leading biomarker-driven CDx or IVD programs bridging bench discovery and clinical application.
• Track record translating biomarker science into validated assays supporting drug approvals.
• Working knowledge of global CDx regulatory pathways (FDA CDRH, EU IVDR, PMDA).
• Ability to translate complex scientific and clinical data for cross-functional and executive audiences.
• Experience managing external partners and multi-workstream programs under QMS/GxP-adjacent conditions.

Responsibilities

• Translate emerging biomarker and mechanism-of-action data into diagnostic target product profiles, defining assay intent across platforms (Next Generation Sequencing, polymerase chain reaction, immunohistochemistry, immunoassays).
• Partner with translational and clinical teams to design biomarker strategies for patient selection, stratification, and enrichment, including sample strategy and specimen logistics.
• Lead analytical and clinical validation planning (accuracy, precision, sensitivity/specificity, limit of detection, reproducibility), linking assay performance to clinical safety and efficacy endpoints.
• Set global CDx strategy for assigned programs, aligning diagnostic milestones with clinical and regulatory timelines.
• Select and oversee In Vitro Diagnostic (IVD) development partners; manage co-development scope, timelines, and quality expectations.
• Support global regulatory strategy and submissions (Food and Drug Administration PMA/supplement, EU IVDR, PMDA) in collaboration with IVD Regulatory, including labeling alignment.
• Ensure compliance with relevant standards (ISO 13485, ISO 14971, CLSI, IVDR, GCP alignment).
• Lead cross-functional working groups, translating scientific rationale into program plans and clear governance reporting.
• Support design transfer, manufacturing readiness, and launch preparation with commercial and medical affairs.

Skills

Biomarker data interpretation

CDx strategy development

Cross-functional leadership

Regulatory knowledge (CDx/IVD)

External partner management

QMS/GxP experience

Platform familiarity (NGS, PCR, IHC, I

Education

PhD in molecular biology / pathology / biomedical engineering

Tools

Next-Generation Sequencing (NGS)

PCR

Immunohistochemistry (IHC)

Immunoassays

Job description

Regeneron Pharmaceuticals, Inc. is seeking an Associate Director to lead companion diagnostic (CDx) strategy and development across biomarker feasibility through clinical validation, regulatory submission, and launch.

You will bridge translational science with diagnostic execution and collaborate with translational, clinical, regulatory, and external IVD partners. The role requires guiding global CDx programs, coordinating cross-functional teams, and ensuring diagnostics align with therapeutic