Clinical Development Scientist

Clinical Development Scientist The Clinical Development Scientist will support the design, execution, and interpretation of clinical studies for oncology-focused in vitro diagnostic products. The scientist will be responsible for developing clinical evidence strategies and managing clinical validation studies suitable for regulatory submissions, for both internal projects and with external partners. The scientist will work cross-functionally with clinical, regulatory, biostatistics, medical affairs, R&D, and quality teams. The scientist will also have opportunities to assist in the product development, analytical validation, and transfer of assay to the clinical laboratory and post-launch support of the products. Essential duties and responsibilities include developing and executing clinical development strategies for oncology IVD products, designing clinical study protocols, managing clinical validation studies from concept through completion, partnering with regulatory affairs to support submission strategy, working closely with R&D, assay development, bioinformatics, quality, and operations teams, analyzing and interpreting clinical study data, contributing to risk assessments, evidence planning, intended-use refinement, claims development, and product launch readiness, and supporting interactions with external collaborators, clinical sites, vendors, key opinion leaders, and regulatory agencies as needed. Essential qualifications include an advanced degree in a relevant scientific, medical, or clinical discipline, at least 5 years post-graduate industry experience, experience designing, managing, and interpreting clinical validation studies for IVD products, experience with IVD product development in oncology, strong understanding of clinical study design, clinical validation principles, clinical evidence generation, and regulatory-grade documentation, ability to work effectively in cross-functional teams, excellent scientific writing and communication skills, and strong organizational skills. Guardant Health