Working closely with Clinical Science physicians, Clinical Operations, Data Management, Biostatistics, Regulatory Affairs, Medical Writing, Biomarker/Translational Research, Pharmacovigilance, and Medical Affairs, the Director, Clinical Science will provide leadership across all phases of development, with particular emphasis on protocol development and study design, data review and interpretation, and data-driven decision making. Author and review clinical sections of regulatory documents, including INDs, CTAs, Investigator Brochures, Clinical Study Reports, briefing packages, periodic safety reports, annual reports, and marketing applications.