Clinical Affairs Scientist

Role: Clinical Affairs Scientist supporting clinical evidence generation for companion diagnostics in oncology, focusing on clinical trial design, study execution, regulatory submissions, and scientific marketing. Responsibilities: lead clinical study development, author protocols/reports, contribute to validation and analytical studies, develop databases and data systems, oversee data quality and statistical analysis, collaborate on regulatory and marketing materials, and serve as a scientific expert in cross-functional and external interactions. 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 within pharma or medical devices; familiarity with clinical trial design, biostatistics, and GxP; strong scientific writing and presentation skills; ability to manage multiple projects and interpret complex data; experience with external partners and regulatory bodies, such as the FDA. Preferred: knowledge in oncology, immunology, or pathology. HighValue: Oncology-focused diagnostics, companion diagnostics, clinical trial oversight, regulatory interactions, GxP compliance. WorkSetup: remote optional; no travel.