Clinical Affairs Scientist

Role: Clinical Affairs Scientist supporting clinical evidence generation for companion diagnostics in oncology within the medical diagnostic sector. Responsibilities: design and oversee clinical trial protocols, contribute to regulatory submissions, generate scientific content including validation studies, and ensure compliance with GxP standards. Collaborate with R&D, Regulatory, Quality, and external partners, including pharma companies and regulatory bodies like the FDA. Provide scientific oversight of marketing materials, author scientific publications, and support audits. Requirements: Master's or advanced degree (e.g., Ph.D., Pharm.D., M.D.) in biomedical sciences, with 4+ years in IVD product development, clinical research, or medical writing. Familiarity with clinical trial design, biostatistics, GCP, and regulatory standards. Strong scientific writing, presentation skills, and ability to manage multiple projects in a fast-paced environment. Preferred: experience in oncology, immunology, or pathology. Work setup: full-time, remote flexibility, no travel.