Clinical Affairs Scientist

Role: Clinical Affairs Scientist supporting clinical evidence generation and co-development of companion diagnostics in oncology. Responsibilities: design and oversee clinical trial protocols, author study reports, contribute to validation and analytical studies, develop databases and eCRFs, ensure data quality and safety, and provide scientific oversight for regulatory submissions and marketing materials. Requirements: Master's or advanced degree (Ph.D., Pharm.D., M.D.) in biomedical or pharmaceutical sciences; 4+ years in IVD product development, clinical research, or medical writing within pharma or medical device sectors; familiarity with clinical trial design, GCP, biostatistics, and regulatory standards; strong scientific and medical writing skills; experience working with external partners and regulatory agencies, including FDA; knowledge of oncology, immunology, or pathology preferred. HighValue: clinical trial design, companion diagnostics, oncology, in vitro diagnostics, regulatory submissions, GCP, biostatistics, medical writing, collaboration with pharma and regulatory bodies. WorkSetup: full-time, remote optional; no travel required.