Over 20 years of clinical research experience adult and pediatric studies. Involved in all aspects of a clinical trial - protocol concept to final protocol through final clinical study reports. One year of Medical Affairs experience. Management and oversight of clinical programs to successfully complete three global Phase 3 studies (Invasive Candidiasis and community acquired bacterial pneumonia). Experienced leader of people and projects that involved oversight and management of multiple Clinical Research Organizations (CROs). Established strong relationships with Clinical Investigators. Knowledge of ICH, GCP, NDA and sNDA submissions and EMEA submissions. Experience working in large pharmaceutical companies and small biotech start up companies. Understand the urgency to get the studies started on-time and completed within budget (Phase 1 through Phase 3B). Nursing background key to understanding diseases under study and training of monitors and other members of the entire project involved in the studies. A Master of Science Degree in Clinical Research Administration.