Clinical Affairs Scientist

Role: Clinical Affairs Scientist supporting oncology companion diagnostics in medical diagnostics. Responsibilities: lead clinical evidence generation, design and oversee clinical studies, contribute to regulatory submissions, ensure scientific validity of results, develop study protocols, manage data systems, and provide scientific oversight for marketing materials. Act as a clinical expert in cross-functional and external stakeholder interactions, including regulatory agencies. Qualifications: Master's degree or higher (Ph.D., Pharm.D., M.D.) in biomedical sciences; 4+ years in IVD product development, clinical research, or medical writing; familiarity with clinical trial processes, biostatistics, and GxP; strong scientific communication skills; experience working with regulatory bodies like FDA. High-Value: oncology, biomarker, in vitro diagnostic development, clinical stage (pre-approval), regulatory compliance, and cross-functional collaboration in pharma/diagnostics sectors. WorkSetup: full-time remote, no travel required.