Clinical Affairs Scientist

Role: Clinical Affairs Scientist supporting clinical evidence generation for companion diagnostics in oncology, with a focus on clinical trial design, study execution, and regulatory submissions. Responsibilities: develop study protocols, contribute to analytical and cutoff studies, design databases and eCRFs, oversee data quality and statistical analysis, collaborate on regulatory documentation including IFUs, and provide scientific oversight of marketing materials. Qualifications: Master's or advanced degree (Ph.D., Pharm.D., MD) in biomedical sciences; 4+ years in clinical research, IVD product development, or medical writing within pharma or diagnostics; familiarity with clinical trial design, GCP, and biostatistics preferred. High-Value: oncology and immunology experience; work involves cross-functional collaboration with R&D, regulatory, and clinical teams; no travel required; remote work option; full-time schedule.