Clinical Affairs Scientist

Role: Clinical Affairs Scientist supporting clinical evidence generation for companion diagnostics in oncology within Agilent's medical diagnostics division. Responsibilities include designing and executing clinical studies, authoring protocols and reports, contributing to validation and analytical studies, developing databases and EDC systems, ensuring data quality, and collaborating with regulatory teams on submissions and documentation. The role entails providing scientific oversight for marketing materials, maintaining SOPs, and serving as a scientific expert in internal and external meetings, including audits and inspections. Requirements: Master's or higher degree in biomedical sciences (Ph.D., Pharm.D., M.D. preferred), 4+ years in IVD product development, clinical research, or related fields, with familiarity in clinical trial design, biostatistics, and GxP standards. Experience working with regulatory agencies such as the FDA and knowledge of oncology, immunology, or pathology are advantageous. Skills include strong scientific writing, project management, and the ability to interpret regulatory standards. Work setup is remote, with a full-time schedule, and no travel expected. The position reports to the Manager of Clinical Affairs Sciences.