Executive Director, Head Epidemiology And Real World Science
Current• Head of Epidemiology and Real World Science department as central group within Alexion, providing epidemiology leadership and Real World Evidence strategy to Alexion-sponsored disease registries, Pharmacovigilance, Regulatory, Clinical Development, Medical Affairs, Commercial strategy, and Business Development initiatives.• First to establish Epidemiology department at Alexion. Formulated department mission and vision statements. Recruited and hired Epidemiologists to develop the department.• Leadership global team with the following accountabilities:--Design and implementation of epidemiologic analyses within Alexion-sponsored registries. --Real World Evidence generation in support of Clinical Development, Regulatory, and Drug Safety stakeholders.--Epidemiology sections of Regulatory and Drug Safety documents including Orphan Drug applications, Risk Management Plans.--Disease epidemiology forecasts for Business Development, Corporate and Commercial Strategy, Target Product Profiles.• Established outsourcing strategy for Epidemiology including identification of preferred vendors.• Oversight of electronic health record platform (TriNetX) for modeling clinical trial protocol inclusion/exclusion criteria, clinical trial site identification and trial recruitment enhancement.• Standing member of R&D governance committees: 1) clinical trial protocol approvals; 2) business development opportunity approvals.• Leadership of R&D process improvement initiative to enhance process for clinical trial protocol development.• Leadership of R&D Innovation team to drive innovative culture across all functions and geographies in the organization.• Recipient of Alexion Guiding Star Award in 2019 and Performance for Patients Award in 2015 (highest Alexion company awards).
