Leading companion diagnostic (CDx) strategy and development, the full-time remote Associate Director Clinical Diagnostics will manage programs from early biomarker feasibility through clinical validation and regulatory submission, ensuring diagnostics align with therapeutic milestones. Key responsibilities Translate biomarker and mechanism-of-action data into diagnostic target product profiles, defining assay intent across various platforms Design biomarker strategies for patient selection and stratification in collaboration with translational and clinical teams Oversee analytical and clinical validation planning, linking assay performance to clinical safety and efficacy endpoints Required qualifications PhD or advanced degree in molecular biology, pathology, biomedical engineering, or related field 8+ years in diagnostics or translational research, with 4+ years leading biomarker-driven CDx or IVD programs Proven track record of translating biomarker science into validated assays supporting drug approvals Working knowledge of global CDx regulatory pathways (FDA CDRH, EU IVDR, PMDA) Experience managing external partners and multi-workstream programs under QMS/GxP-adjacent conditions
Associate Director Clinical Diagnostics in workfromhome at Unknown Company
This position is listed as full time and able to be worked remotely.