Clinical Development Scientist

Clinical Development Scientist to design, execute, and interpret oncology-focused clinical studies for in vitro diagnostic products. Responsible for developing clinical evidence strategies, managing clinical validation studies for regulatory submissions, collaborating with regulatory affairs, biostatistics, and cross-functional teams, and contributing to product development, analytical validation, and post-launch support. Role involves creating clinical study protocols, analysis plans, data review, and communication of results to internal and external stakeholders, with focus on regulatory-ready evidence packages and risk assessments for product claims. Preferred experience with NGS-based IVD development, regulatory submissions (FDA/IVDR/PMAs/De Novo/510(k)), and familiarity with GCP, GLP, CAP, ISO 13485 and related IVD standards. Hybrid work model with on-site days in the Bay Area; includes collaboration across clinical sites, vendors, and external partners; strong scientific writing and project-management skills required.