Proven innovative senior level clinical development operations professional with over 20 years experience in biotechnology, device, and pharmaceutical companies. Successfully developed and managed Clinical Operations, Global Pharmacy and Logistics, Clinical Outsourcing, Clinical Document Information Center, Contract Management, Training & SOPs, Biostatistics, Data Management, Project Management, R&D Quality Assurance, and Manufacturing Production Planning departments.• Extensive international clinical development experience in all phases of clinical development and populations. • Meticulously managed cost center budgets up to $75M and 81 people.• Relentless drive to gain process efficiencies and develop novel and innovative approaches with programs and development partners.• Led multiple successful FDA and EMA inspections and contributed to three successful New Drug Applications and Marketing Authorization Applications.