Accomplished strategic thinker research physician and medical monitor with extensive experience in the global pharmaceutical industry in multiple therapeutic areas. Over a decade of clinical research and drug development experience in the pharmaceutical industry, CRO, and academia. Experienced in a broad range of functional areas including Clinical Development from First-in-human (Phase 1) through post-marketing, clinical studies design, PROs, Medical Monitoring, CSRs execution, and regulatory involvement with multiple regional health authorities (e.g., FDA, EMA, PMDA). Track record of results-oriented high-performance demonstrated in developing, executing and monitoring complex clinical studies to deliver high-quality strategic outcomes.
Therapeutics areas of expertise: oncology, neurology, cardiovascular, ophthalmology, rare disease, paediatrics, gene therapy, immunology, NASH, general internal medicine.
Clinical Trials experience Phase I (First-In-Human, Dose-escalation, Drug-Drug interaction, Food interaction, bioavailability), Phase II, Phase III confirmatory, post-marketing registry studies. Pregnancy registry and paediatrics studies.