Drafts, reviews and approves internal and external study-related plans, processes, and documents including Informed Consent Forms, Investigator Agreements (CTA), CRFs, CRF Guidelines, statistical/pharmacokinetic analysis plans, monitoring plans, data management plans, and safety monitoring activities. The ideal candidate thrives in a fast-paced, entrepreneurial environment, demonstrates exceptional operational leadership, and possesses strong business acumen with an understanding of the competitive landscape, capital allocation, and value creation throughout drug development.