Associate Director, CDx Strategy & Diagnostic Development

BioSpace; Kuah; On-site; MYR 415,000 - 675,000; Full time

Job summary

Regeneron is seeking an Associate Director to lead companion diagnostic (CDx) strategy and development, bridging translational science with diagnostic execution. You will own CDx programs from early biomarker feasibility through clinical validation, regulatory submission and launch, translating biological insights into validated, fit-for-purpose assays to guide drug development decisions.

The role interfaces with biomarker science, clinical development, regulatory, and external IVD partners to

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).
• Partner with translational and clinical teams to design biomarker strategies for patient selection and enrichment.
• Lead analytical and clinical validation planning and link assay performance to safety and efficacy endpoints.
• Set global CDx strategy aligning diagnostic milestones with clinical and regulatory timelines.
• Select and oversee IVD development partners; manage co-development scope and timelines.
• Support global regulatory strategy and submissions (FDA PMA, EU IVDR, PMDA).
• Ensure compliance with standards (ISO 13485, ISO 14971, CLSI, IVDR, GCP).
• Lead cross-functional working groups and governance reporting.
• Support design transfer, manufacturing readiness, and launch preparation with commercial and medical affairs.

Skills

CDx strategy

Biomarker development

Clinical validation

Cross-functional leadership

Regulatory awareness

External partnerships

Education

PhD or advanced degree in molecular biology, pathology, biomedical engineering, or related translational/biomedical science

Job description

Regeneron is seeking an Associate Director to lead companion diagnostic (CDx) strategy and development, bridging translational science with diagnostic execution. You will own CDx programs from early biomarker feasibility through clinical validation, regulatory submission and launch, translating biological insights into validated, fit-for-purpose assays to guide drug development decisions.

The role interfaces with biomarker science, clinical development, regulatory, and external IVD partners to