More than 25 years of hands-on experience and working knowledge in clinical development and operations in both diagnostics and therapeutics at the Senior Director and Vice President capacity. Track record includes delivering supportive clinical data culminating in multiple NDA/BLA and PMA/510(k) product approvals in the US and EU. Experienced in leading highly motivated in-house clinical and cross-functional teams, vendors and CROs in strategic planning and execution of early to late phase clinical trials in oncology, immunotherapy, CNS, CVD and upper respiratory disorders in a cost-effective and timely manner. Experienced in planning and executing complex, hard to recruit, large global studies across 5 continents. Authored publications, protocols, study documents, training material and mentored direct reports.