Dedicated, passionate, strategic clinical development professional offering Global expertise in clinical operations and other cross-functional areas, including regulatory, data management, biostatistics, CMC, and nonclinical with a focus on contingency planning in dynamic, flexible environments. Innovative business partner, effective communicator, and problem-solving project manager known for developing and nurturing positive, productive relationships to maintain quality standards with partners in the Americas, Asia Pacific, the EU, and the UK. Collaborative leader and individual contributor with demonstrated success in early-stage biotech working with diverse, cross-functional teams to adapt to dynamic changes with a spirit of pragmatic optimism.CORE COMPETENCIESClinical Operations / Phases 1,2,3 / Project Management /Vendor / Consultant Management / Protocol Development / Cross-Functional Leadership / ICH/GCP / IND/CTA Submissions / Timelines / Budgets / Contracts / Monitoring / Risk Mitigation / Clinical Content Contributor / Advisory Board/KOL management / Strategic Flexibility / Nimble / ProactiveTECHNICAL PROFICIENCIESBoard & Management Presentations / Data Review Committee / Safety Monitoring Board / Investigator Meetings / EDC / IWRS / Clinical Supplies – Packaging, Labeling, Inventory Management / Clinical Study Reports / Communication / Mentoring / Quality Assurance / MetricsTHERAPEUTIC AREAS Oncology / Infectious Disease / Ophthalmology / Neurology / Inflammation / CNS / Metabolic / Gastrointestinal