Over the past 20 years working in Drug Development and Clinical Operations in biotech and pharma, I have established and led operations for companies including Gilead, Telavant, AbbVie and AMT implementing and managing all phases of human subject research including pre-clinical, Phases I-V, and post-market clinical trials.During this time, I have worked across a wide variety of therapeutic areas, including oncology, inflammation, neurology/CNS, infectious disease, rare disease and internal medicine in pediatric, adult, elderly and special populations. Some highlights include:*Global Development & Clinical Operations Leadership: Initiate, create infrastructure and manage global operations for studies across 40+ countries in 500+ sites, including U.S., EU and Eastern Europe, Japan, India, and South America with budget accountability up to $1B. Vendor management including the selection and management of CMC, CRO, and a wide variety of specialty vendors and investigative sites.*Team Builder & Leader: Assemble and lead world-class teams with an emphasis on training and personal development. Restructure team and position structure to enable global coverage, and integrate teams and functions post-acquisitions. Extensive experience managing cross-functional clinical operations teams.*Deep Experience Across all Levers of Development: Oversight of supportive functions outside of Clinical Operations, inclusive of Regulatory, Medical Writing, Clinical Supply, Vendor Relations/Selection and Management. Well versed in the conduct of clinical research regulations including ICH-GCP, FDA and EMA.Additionally, I have deep experience collaborating with CMOs and other executive leaders on Clinical Development strategies and Trial Design, have led all phases of trial management from trial conception and initiation to shutdown and close-out of studies, and have created all Standard Operating Procedures inclusive of CRO Oversight, Trial Conduct, Protocol Writing, Data Collection and more.My experience shows me that I thrive in fast-paced environments where creativity and collaboration are essential in overcoming obstacles, and where direct, transparent communication is valued and implemented. As a manager overseeing global teams, I have tried hard to lead by example, always respecting the diversity and humanity of my team members.