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: develop study protocols, author validation and analytical studies, design databases and eCRFs, monitor trial quality, ensure data validity, contribute to regulatory submissions including IFUs, oversee scientific validity of results, author scientific publications, and support audits. Qualifications: Master's or advanced degree (e.g., Ph.D., Pharm.D., M.D.) in biomedical or medical science; 4+ years in IVD product development, clinical research, or medical writing; familiarity with clinical trial conduct, biostatistics, and GxP; strong scientific and medical communication skills; experience with external partnerships and regulatory agencies, especially FDA; knowledge of oncology, immunology, or pathology preferred. HighValue: oncology, companion diagnostics, in vitro diagnostics, clinical trial design, regulatory submissions, scientific communication. Work setup: full-time, remote option; no travel required.