Clinical Affairs Scientist

Role: Clinical Affairs Scientist supporting clinical evidence generation for companion diagnostics in oncology, focusing on clinical trial design, execution, regulatory submissions, and scientific marketing. Responsibilities: lead study protocol development, contribute to validation and analytical studies, design databases and eCRFs, ensure data integrity and compliance, and provide scientific oversight for regulatory and marketing materials. Requirements: Master's degree or higher (Ph.D., Pharm.D., M.D.), 4+ years in IVD product development, clinical research, or medical writing within medical device or pharmaceutical sectors; familiarity with clinical trial processes, biostatistics, and GxP standards. HighValue: oncology diagnostics, companion diagnostics development, clinical trial oversight, regulatory collaboration including FDA interactions, experience with analytical concordance and risk analyses, and scientific publication authoring. WorkSetup: full-time remote options; no travel.