This role will help build and operationalize the company's Clinical Affairs infrastructure, including SOPs, templates, trial master file structure, CRO/vendor oversight practices, and study governance, while serving as a key liaison between Regulatory Affairs, Medical Affairs, Development, Quality, Biostatistics, Data Management, and commercial stakeholders. Develop and implement Clinical Affairs SOPs and processes for study feasibility, protocol development, IRB/EC submissions, informed consent, site qualification and initiation, monitoring, deviation management, safety reporting, data management interface, trial master file management, and study closeout.