Clinical Affairs Scientist

Role: Clinical Affairs Scientist supporting clinical evidence generation for companion diagnostics in oncology, focusing on clinical trial design, execution, and regulatory submissions. Responsibilities: provide scientific leadership, design studies, develop databases and EDC systems, contribute to risk analyses and data monitoring, ensure scientific validity of results, collaborate on regulatory documentation and marketing materials, maintain SOPs, act as clinical science SME in cross-functional and external meetings, author scientific publications, and support audits. Qualifications: 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 medical device/pharma industries. Skills: clinical trial design, biostatistics, GCP familiarity, scientific/medical writing, project management, regulatory interpretation, with preferred expertise in oncology, immunology, or pathology. Work setup: full-time remote option, no travel required.