Clinical Affairs Scientist

Role: Clinical Affairs Scientist supporting clinical evidence generation for in vitro diagnostic companion diagnostics in oncology. Responsibilities: design and execute clinical trials, develop study protocols and reports, contribute to regulatory submissions, oversee data management and analyses, and ensure scientific validity of results. Collaborate with cross-functional teams including R&D, Quality, and Regulatory, and provide scientific oversight of marketing materials. Qualifications: Master's degree or higher (Ph.D., Pharm.D., M.D.) in biomedical sciences; 4+ years in clinical research, IVD product development, or medical writing; familiarity with clinical trial design, GxP, biostatistics, and regulatory standards, especially in the pharma or medtech industry. HighValue: oncology, companion diagnostics, clinical trial oversight, regulatory submissions, medical/scientific writing, cross-functional collaboration. WorkSetup: full-time, remote option; no travel required.