Senior CDx Strategy Lead – Precision Diagnostics

Initial Therapeutics, Inc.; Armonk (NY); On-site; USD 176,000 - 287,000; Full time

Job summary

Regeneron seeks an Associate Director to lead companion diagnostic strategy, translating translational science into validated CDx assays that inform drug development decisions. You’ll oversee biomarker programs from feasibility through clinical validation and launch, coordinating with translational, regulatory, and external IVD partners.

You will drive global CDx strategy, manage partner co-development, ensure regulatory alignment, and translate complex data for executive audiences while

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.
• Experience translating biomarker science into validated assays for drug approvals.
• Experience with global CDx regulatory pathways (FDA CDRH, EU IVDR, PMDA).
• Ability to translate complex scientific 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 data into diagnostic target product profiles across platforms.
• Design biomarker strategies for patient selection, stratification, and enrichment including sample strategy.
• Lead analytical and clinical validation planning and link assay performance to clinical endpoints.
• Set global CDx strategy aligning diagnostic milestones with regulatory timelines.
• Oversee IVD development partners; manage co-development scope, timelines, and quality expectations.
• Support regulatory submissions (FDA PMA/supplement, EU IVDR, PMDA) with labeling alignment.
• Ensure compliance with ISO 13485/14971, CLSI, IVDR and GCP alignment.
• Lead cross-functional governance reporting and drive design transfer and manufacturing readiness.
• Support launch preparation with commercial and medical affairs.

Skills

CDx strategy

Biomarker development

Cross-functional leadership

External partner management

Education

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

Job description

Regeneron seeks an Associate Director to lead companion diagnostic strategy, translating translational science into validated CDx assays that inform drug development decisions. You’ll oversee biomarker programs from feasibility through clinical validation and launch, coordinating with translational, regulatory, and external IVD partners.

You will drive global CDx strategy, manage partner co-development, ensure regulatory alignment, and translate complex data for executive audiences while