Clinical Affairs Scientist

Role: Clinical Affairs Scientist supporting clinical evidence generation for oncology companion diagnostics within a global medical diagnostics organization. Responsibilities include designing and executing clinical studies, authoring protocols and reports, contributing to validation and analytical studies, developing data collection systems, and ensuring scientific validity of results. The role involves collaboration with pharmaceutical partners, R&D, regulatory, and quality teams, providing scientific oversight on marketing materials, and supporting regulatory submissions and audits. 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, with familiarity in clinical trial design, biostatistics, and GxP standards. Strong scientific communication and project management skills are essential, with experience working with external partners or regulators like the FDA preferred. High-value: Oncology, immunology, or pathology experience; clinical study oversight; regulatory interactions; focus on companion diagnostics development. Work setup: Full-time, remote options; no travel required.