Clinical Development Scientist, Senior Manager

Role: Senior Manager, Clinical Development Scientist overseeing clinical trials in Internal Medicine, with responsibility for scientific oversight, data integrity, and quality assurance across studies. Responsibilities include contributing to protocol design, supporting study governance and safety plans, data review, safety monitoring, site selection, investigator interactions, and regulatory documentation. The role also entails mentoring team members, supporting audits, and contributing to publications and regulatory submissions. Requirements: PhD, PharmD, or equivalent with 1+ years (or MA/MS with 5+ years, BA/BS with 6+ years) industry experience in clinical research; strong knowledge of clinical development processes, GxP, ICH/GCP, and experience in regulatory interactions. Preferred: cardiometabolic disease expertise, experience in study start-up and regulatory filings, publication record, leadership skills, and ability to manage complex projects. High-Value: focus on clinical trials in Internal Medicine, potentially involving biologics or small molecules, with responsibilities spanning from protocol development through to data analysis and safety oversight. Work setup: hybrid in U.S., requiring on-site presence ~2.5 days/week, with potential for global travel.