20+ years of experience in drug discovery and clinical development including management of phase I, II, and III studies.
Expertise in Early Development including developing strategy for 15+ IND/FIH submissions. Developed strategy for execution of over 200 clinical pharmacology studies to support Phase II/III and NDA filings
Experience with large international Phase 3 studies (up to 5400 patients) implementing novel approaches to meet development program goal of accelerated NDA submissions. Participated in sponsor and investigational site inspection readiness activities as part of scheduled and potential regulatory agency inspections
Member of Development Operations leadership team to develop strategy and goals to drive higher capabilities, productivity and quality levels. Participated in R&D Quality and Compliance routine audits to identify process gaps, develop corrective actions plans, and implement training plans
Created a highly motivated teams through effective leadership, coaching and people management ensuring an objective and performance-led management culture.
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