St. Petersburg, Florida, United States
Board Certified Dermatologist with extensive combined clinical practice and clinical research experience. Expertise in clinical trials, clinical drug development (phase I to IV) in rare diseases, complex medical dermatology (including use of biologics), surgical dermatology, cosmetic dermatology (neurotoxins, fillers, lasers).
Serve as Dermatology subject matter expert / consultant providing detailed clinical development strategies for phase I to IV Dermatology trials including rare diseases, RFP/RFI and consulting projects. Heavily involved in clinical trial protocol development, regulatory strategy and submission, and study execution strategies. Provide medical and scientific data review as well as support/provide guidance to operational teams in all aspects of clinical research and other consulting projects. Liaise with internal and external experts, clinical trial site specific principal investigators and study teams to produce high quality clinical development programs.
Serve as Dermatology consultant for various clinical trials, Current Lead Medical Monitor for Global Phase 2 Trial with 80+Sites
Serve as Principal Investigator or Sub-I for various Dermatology specific clinical trials. Involved with protocol design, evaluation of feasibility of studies, and ensuring studies/protocols are in compliance with GCP/ICH guidelines. Assess for/monitor/document adverse events/outcomes, deviations from protocol during clinical trial activities.