CDx Strategy Lead for Precision Medicine & Diagnostics

Regeneron Pharmaceuticals, Inc; Dublin; On-site; EUR 102,000 - 165,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks an Associate Director to lead companion diagnostic (CDx) strategy and development, bridging translational science with diagnostic execution.

This role owns CDx programs from early biomarker feasibility through clinical validation, regulatory submission, and launch — translating biological insights and clinical hypotheses into validated, fit-for-purpose assays that support drug development decisions.

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 (TPPs), 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

CDx strategy

Biomarker translation

Regulatory knowledge

Cross-functional leadership

Education

PhD in molecular biology or related field

Job description

Regeneron Pharmaceuticals, Inc. seeks an Associate Director to lead companion diagnostic (CDx) strategy and development, bridging translational science with diagnostic execution.

This role owns CDx programs from early biomarker feasibility through clinical validation, regulatory submission, and launch — translating biological insights and clinical hypotheses into validated, fit-for-purpose assays that support drug development decisions.