Senior Manager, Clinical Diagnostics CDx (Precision Medicine)

Role: Senior Manager, Clinical Diagnostics, leading end-to-end companion diagnostics (CDx) strategy and execution across therapeutic indications, supporting assay development from feasibility to validation, registration, and post-market activities. Responsibilities: manage cross-functional teams and IVD partners, define assay intent and contribute to target product profiles for platforms like NGS, PCR, IHC; oversee analytical and clinical validation; embed assays in clinical trials for screening and stratification; partner on global regulatory submissions (FDA, EU IVDR, PMDA); ensure compliance with quality and regulatory standards; provide transparent updates to senior leadership. Requirements: advanced degree in molecular biology, pathology, or biomedical engineering; 4+ years in diagnostics development with 2+ years leading CDx/IVD programs; proven success in regulatory submissions and validation; expertise in NGS, PCR, IHC, immunoassays; familiarity with global regulatory pathways; strong communication and stakeholder management skills. HighValue: diagnostics development, CDx strategy, global regulatory (FDA, IVDR, PMDA), NGS, PCR, IHC, validation, clinical trial integration, GxP compliance. WorkSetup: onsite Tarrytown, NY; travel up to 10% for partner meetings, site visits, regulatory interactions.