Clinical Affairs Scientist

Role: Clinical Affairs Scientist supporting clinical evidence generation for in vitro diagnostic companion diagnostics in oncology. Objectives include designing and executing clinical trials, contributing to regulatory submissions, and ensuring scientific validity of results. Responsibilities encompass study protocol development, data management, risk analysis, regulatory collaboration, and scientific communication such as manuscripts and presentations. The candidate will provide clinical oversight of marketing materials and support audits. Requirements: Master’s or advanced degree (e.g., Ph.D., Pharm.D., M.D.) in biomedical sciences; 4+ years in IVD product development, clinical research, or medical writing, preferably in pharma or medical devices. Skills in clinical trial design, biostatistics, and regulatory standards are preferred. Knowledge in oncology, immunology, or pathology is advantageous. The role demands strong scientific and medical writing skills, project management, and experience working with external partners and regulatory agencies like the FDA. Work setup offers full-time remote flexibility with a daytime schedule. No travel required. High-value specifics include focus on oncology diagnostics, clinical trial oversight, and regulatory engagement within a fast-paced, cross-functional environment.