Clinical Affairs Scientist

Role: Clinical Affairs Scientist supporting clinical evidence generation for companion diagnostics in oncology, focusing on clinical trial design, execution, and regulatory documentation. Responsibilities: develop study protocols, manage data collection systems, ensure scientific validity of results, collaborate on regulatory submissions, oversee clinical quality, and contribute to scientific publications and presentations. Qualifications: Master's or advanced degree (e.g., Ph.D., Pharm.D., M.D.) in biomedical sciences; 4+ years in IVD product development, clinical research, or medical writing; familiarity with clinical trial conduct, biostatistics, GCP, and regulatory standards; strong scientific and communication skills. HighValue: oncology, diagnostic development, clinical trial oversight, regulatory interactions, biopharma partnerships. WorkSetup: full-time remote option; no travel required.