Clinical Affairs Scientist

Role: Clinical Affairs Scientist supporting clinical evidence generation for companion diagnostics in oncology within the medical diagnostics field. Responsibilities: design and oversee clinical trial studies, contribute to regulatory submission documents, generate scientific content for validation studies, and ensure compliance with quality standards. Collaborate with pharmaceutical partners, R&D, regulatory, and quality teams; provide scientific oversight on marketing materials; author manuscripts and presentations; support audits and inspections. 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, preferably in pharma or medical devices; familiarity with clinical trial design, biostatistics, and GxP; strong scientific and communication skills; experience working with regulatory agencies like the FDA. Preferred: knowledge in oncology, immunology, or pathology. HighValue: oncology diagnostics, companion diagnostics, clinical trial design, regulatory submission, medical and scientific writing. WorkSetup: full-time, remote option; no travel required.