Description
Senior project management and implementation experience with a fifteen year track record of successful directing, analyzing, tracking, and managing global clinical research, quality improvement and system integration programs, including 12 years of direct pharmaceutical trial management experience. Managed U.S. and global clinical trials and cross functional global teams phase 1 through 4 from study start to DB lock and CSR under FDA, GCP, ICH, EMEA and federal regulatory guidelines. Five NDA filings including blockbuster drugs: Ezetimbe (Schering Plough) and Plavix w Aspirin (Bristol Myers Squibb). Quality Assurance of submissions INDs, IND AEs, CTAs, MAAs, NDAs and monthly investigator updates to the regulatory authorities. Proficient in Project Management Institute PMBOX, Six Sigma DMAIC and & Lean Methodology tools including RCA, FMEA, and Fishbone. Exceptional scientific knowledge in biomedical informatics, behavioral health, clinical and translational research. Multiple therapeutic areas expertise: Allergy, Cardiovascular, Endocrinology, Maternity, Obstetrics, Oncology, Pediatric rehabilitative Medicine and Women Health.
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