Clinical Affairs Scientist

Role: Clinical Affairs Scientist supporting clinical evidence generation for companion diagnostics in oncology, focusing on clinical trial design, execution, regulatory submissions, and scientific marketing. Responsibilities: lead study design, author protocols/reports, develop databases and eCRFs, oversee data quality and analysis, collaborate on regulatory documentation including IFUs, and provide scientific oversight of marketing materials. Serve as a subject matter expert in clinical science, supporting audits and preparing scientific publications. Requirements: Master's or advanced degree (e.g., Ph.D., Pharm.D., M.D.); 4+ years in IVD product development, clinical research, or medical writing; familiarity with clinical trial conduct, biostatistics, and GCP; strong scientific and medical communication skills; ability to manage multiple projects in a fast-paced environment; experience with external partners/regulatory bodies, including FDA. Preferred: knowledge in oncology, immunology, or pathology. HighValue: medical diagnostics development, oncology focus, clinical trial oversight, regulatory interactions, strong emphasis on scientific communication. WorkSetup: remote optional; full-time schedule; no travel required.