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 include developing study protocols and reports, designing databases and EDC systems, ensuring data quality, and providing scientific oversight for regulatory and marketing materials. The role also involves collaboration with pharma partners, R&D, Regulatory, and QA teams, along with authoring scientific publications and supporting audits. 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 device sectors. Familiarity with clinical trial conduct, biostatistics, GCP, and regulatory standards is preferred. Additional skills include strong scientific writing, project management, and experience working with external agencies like the FDA. Preferred: Oncology, immunology, or pathology expertise. Work setup: remote, full-time, day shift; no travel required. Seniority: mid-level professional with 4+ years of relevant experience.