Overview of Skills and Experience

I have more than twenty five years of experience in positions that involved responsibilities for the development and implementation of multi-disciplinary clinical and drug research programs, both in the USA and overseas.
 
I have benefited from a unique and varied professional education and work experience. As a physician who holds a PhD in Epidemiology, I have been able to use my skills to bridge the gap between the fields of Medicine, Epidemiology, and Biostatistics in the drug development research arena. I have a sound knowledge of research methodology as well as a strong understanding of the research process. My background has been further enriched by working in diverse academic, industry, and regulatory settings.
 
In Merck, I supervise a staff of professional and medical epidemiologists and have the overall responsibility for worldwide epidemiologic activities providing global Epidemiology Therapeutic Area leadership for oncology, diabetes, cardiovascular, and benefit-risk franchises. I established a multidisciplinary cross-functional team to provide guidance to early- and late-stage product teams regarding the selection and deployment of benefit-risk frameworks and methodologies.
 
During my tenure at the Food and Drug Administration (FDA), I have worked in both the pre-marketing and post-marketing settings. First, as a member of a specialized drug safety team in an Office of New Drugs reviewing division, I worked on safety issues with neurology and psychiatry drugs that arose during clinical development, the NDA review stage, and the post-marketing period. Subsequently, I enhanced my drug safety experience by working with large electronic medical records and insurance claims databases on post-marketing safety issues for a variety of drugs in the Office of Surveillance and Epidemiology. Additionally, as part of my professional development time, I have contributed to various research projects at the universities where I hold several academic appointments.
 
I am always keen on participating in training courses inside and outside my organization and attending various scientific conferences on a regular basis to keep abreast of new developments in the scientific field. During my educational journey, I accumulated a wealth of knowledge and skills that I always seek to apply to my work. I count among my skills knowledge of research design and its impact on safety data interpretation, ability to integrate safety information from different sources and use different approaches to explore safety data, and ability to understand, uncover, and explain limitations in research data, and to use complex analytical techniques.
 
I have a positive professional demeanor and enjoy excellent interpersonal communication skills. In fact, I have received several commendations for my dedication and professionalism, and continue to receive recognition for my communication skills and leadership excellence. In addition, I have been praised by many of my colleagues who describe me as professional, self-motivated, humble, eager to learn, and capable of assuming greater responsibilities.
 

Highlights 

  • Over 25 years of experience and scientific knowledge applicable to the development, evaluation, and use of medical products with strong ability to handle crisis situations.
  • Extensive experience in directing a multi-disciplinary scientific organization including responsibility for planning, management, analysis, direction, and evaluation of programs related to efficacy and safety of medical products.
  • Strong, collaborative, and collegial leadership style with hands-on experience in recruiting, managing, and mentoring highly qualified multidisciplinary teams of health professionals, medical doctors, epidemiologists, statisticians, and pharmacists.
  • Distinguished record of research leadership including experience building a successful research program with ability to work across a portfolio of research topics simultaneously.
  • Specialized senior level experience in directing programs in post-market surveillance, post-market studies, statistical reviews, epidemiological analyses, and knowledge management.
  • In-depth knowledge of epidemiology and statistical principles pertinent to the design, conduct, analysis, and presentation of clinical trials and observational studies of drug efficacy and safety, with a strong ability to bridge the gaps between the clinical and the analytic disciplines.
  • Strong analytic skills and expertise in interpretation and presentation of high profile scientific findings to audiences with diverse background.
  • Ability to translate complex scientific concepts and ideas easily to a broad audience in layman’s terms.
  • Knowledge and experience in the regulation of products under the U.S. Food and Drug Administration and European Medicines Agency.
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