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 overseeing clinical study protocols, authoring validation studies, ensuring regulatory compliance, and providing scientific oversight for marketing materials. The role entails collaboration with pharma partners, R&D, clinical teams, QA, and regulatory bodies, with a focus on clinical research, data analysis, and documentation. Requirements: Master’s or advanced degree (Ph.D., Pharm.D., M.D.) in biomedical sciences; 4+ years in IVD product development, clinical research, or medical writing; familiarity with clinical trial design, biostatistics, GxP, and regulatory standards, especially FDA regulations. Preferred: experience in oncology, immunology, or pathology. High-value: oncology diagnostics, companion diagnostics, clinical development, regulatory submissions, and cross-functional collaboration. Work setup: full-time, remote option, no travel.