Overview of Skills and Experience
I have more than 30 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.
I am always keen on keeping 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.
Over 30 years of experience and scientific knowledge applicable to the development, evaluation, and use of medical products with strong ability to handle crisis situations.
A recipient, among many other awards, of the FDA Distinguished Service Award and the Frances Kelsey Excellence in Drug Safety Award.
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 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 audience with diverse background.
Ability to translate and communicate 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.