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: develop study protocols, author validation study content, design databases and EDC systems, ensure data quality and compliance, provide scientific oversight of marketing materials, author manuscripts and presentations, and support audits. Qualifications: Master’s or higher degree (Ph.D., Pharm.D., M.D.) in biomedical sciences; 4+ years experience in IVD product development, clinical research, or medical writing within pharma or medical device sectors; familiarity with clinical trial design, biostatistics, and GCP preferred. High-Value: oncology, in vitro diagnostics, companion diagnostics, clinical trial oversight, regulatory submission support, scientific communication. WorkSetup: full-time remote options; no travel required.