Senior clinical scientist, senior clinical research associate, project manager, regulatory affairs consultant, medical writer, and clinical pharmacokinetics with over 25 years of experience in clinical research, clinical data interpretation, pharmacokinetics, training, regulatory affairs, and scientific writing.
Experienced in performing study monitoring, regulatory auditing of GLP and GCP research laboratories and investigative sites, and clinical research professional training.
Experienced in clinical development plan and regulatory affairs strategic planning, project and program management, study protocol and preparation, clinical data interpretation, writing clinical study reports, regulatory submissions, manuscripts, and abstracts. Extensive clinical trials experience over the past 25 years in Phase I-IV clinical trials in cardiovascular and endocrine/metabolic disorders (e.g., hypertension, heart failure, angina, myocardial infarction, dyslipidemias, diabetes mellitus, metabolic syndrome, obesity, osteoporosis), neurology, and psychiatric disorders (neuromuscular disorders, Alzheimer's disease, epilepsy, autism, post-traumatic stress disorder, intermittent explosive disorder, anxiety, depression, and schizophrenia) and oncology. Additional therapeutic experience in dermatology, immunology, infectious diseases, hormone replacement therapy, urology, ophthalmology, rheumatoid arthritis, analgesia, gastroenterology, substance abuse disorders, and high-risk pregnancy.