Clinical Affairs Scientist

Role: Clinical Affairs Scientist supporting clinical evidence generation for companion diagnostics in oncology, within the medical diagnostic field. Responsibilities: lead clinical trial design, contribute to validation and analytical studies, develop databases and EDC systems, ensure data integrity, collaborate on regulatory submissions (including clinical performance and IFU documentation), provide scientific oversight of marketing materials, author scientific publications, and support audits/inspections. Requirements: Master's or higher degree (Ph.D., Pharm.D., M.D.) in biomedical sciences; 4+ years in IVD product development, clinical research, or medical writing, preferably in pharma/medical devices. Skills: strong scientific and medical writing, experience with clinical trial design, biostatistics, GxP, and regulatory standards; ability to manage multiple projects independently. Preferred: oncology, immunology, or pathology knowledge; familiarity with FDA interactions. HighValue: focus on oncology diagnostics, clinical trial oversight, regulatory engagement, scientific communication, and cross-functional collaboration. WorkSetup: full-time, remote work option, no travel required.