Clinical Affairs Scientist

Role: Clinical Affairs Scientist supporting clinical evidence generation for companion diagnostics in oncology, focusing on study design, execution, and regulatory documentation. Responsibilities: develop protocols, contribute to validation and analytical studies, oversee data collection and analysis, ensure scientific validity of results, and author scientific publications. Collaborate with R&D, Regulatory, and Quality teams; support audits and inspections; maintain compliant clinical processes; provide clinical oversight on marketing materials; and contribute to regulatory submissions. Requirements: Master's degree or higher (Ph.D., Pharm.D., M.D.) in biomedical or related fields; 4+ years in IVD or medical device/pharmaceutical clinical research, medical writing, or clinical science; familiarity with trial design, biostatistics, and GCP; strong scientific and communication skills; ability to manage multiple projects in a fast-paced environment; experience with external partners or regulatory bodies, including FDA. Preferred: experience in oncology, immunology, or pathology. High-Value: clinical research in diagnostics, companion diagnostics, oncology, regulatory compliance, biopharma collaboration, and medical device/pharma industry experience. Work Setup: full-time, remote option; no travel required.