Associate Director, Precision Medicine (Clinical Diagnostics)

Role: Associate Director leading companion diagnostic (CDx) strategy and development, bridging translational science with diagnostic execution across early biomarker feasibility to regulatory approval and launch. Responsibilities: translate biomarker data into diagnostic target profiles; collaborate with translational and clinical teams on assay strategies for patient selection and enrichment; oversee analytical and clinical validation of assays; set global CDx strategies aligned with clinical and regulatory milestones; manage external IVD partners and oversee co-development; support regulatory submissions (FDA, EU IVDR, PMDA); ensure compliance with GxP standards; lead cross-functional teams translating scientific rationale into program plans; assist with design transfer, manufacturing readiness, and launch activities. Requirements: PhD or equivalent in molecular biology, pathology, biomedical engineering, or related field; 8+ years in diagnostics or translational research with 4+ years leading biomarker-driven CDx/IVD programs; proven track record in translating biomarker science into validated clinical assays supporting drug approvals; knowledge of global regulatory pathways (FDA, EU, Japan); ability to communicate complex data to diverse audiences; experience managing external partners within QMS/GxP frameworks. High-Value: focus on biomarker-based diagnostics, assay development across platforms (NGS, PCR, IHC, immunoassays), regulatory submission support, and cross-functional leadership. Work setup: on-site 4 days/week in Armonk, NY, Cambridge, MA, or Warren, NJ.