Executive Director, Global Regulatory Policy, Research & Engagement
Clarksville Maryland UNITED STATES
Regulatory affairs and policy executive with over 10 years of experience and expertise in key areas including drug development, prescription drug promotion, labeling, policy development, and drug safety. Skilled at effective coalition building, strategic planning, program implementation, and evaluation. Extensive knowledge in science, healthcare and law, including over seven years of experience at the Food and Drug Administration. Demonstrated record of building and leading strong interdisciplinary teams, developing business relationship strategy, and engaging in matrixed organizations. CURRENT POSITIONS 1. Executive Director, Global Regulatory Policy, Research & Engagement at BioMarin Pharmaceutical Inc. Executive lead responsible for driving BioMarin’s global regulatory policy and health authority engagement, regulatory research and intelligence, and patient engagement and outcomes research functions. Lead a global cross-functional group in providing strategic insights to support decision-making across BioMarin’s portfolio, including gene therapy products. Support overall World Wide Research and Development (WWRD) strategic planning as part of BioMarin’s WWRD Leadership team and Global Regulatory Affairs Leadership team. 2. Adjunct Professor; Health Services Management Program in the School of Undergraduate Studies at the University of Maryland University College Provide instruction for the Legal and Ethical Issues in Healthcare, and Management in Healthcare Organizations courses. LAST POSITION Director, Division of Medical Policy Development, Office of Medical Policy (OMP), Center for Drug Evaluation and Research (CDER), FDA. EDUCATION: Juris Doctor (admitted to the Maryland State Bar) University of Maryland, Francis King Carey School of Law Post-Doctoral Medical Affairs Fellowship, Procter & Gamble Pharmaceuticals Pharmacy Practice Residency, Georgetown University Hospital Doctor of Pharmacy (Licensed in the District of Columbia), Howard
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