Alexander Cole
- Role
- Executive Director, Head Epidemiology and Real World Science at Alexion Pharmaceuticals, Inc.
- Location
- Chelmsford, MA, US
- LinkedIn followers
- 500 followers
About Alexander Cole
I’m a strategic and scientific leader in Epidemiology and Real-World Evidence (RWE)…
Experience
Executive Director, Head Epidemiology and Real World Science
Jan 2019 — Present
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).
Skills
- Pharmacoepidemiology
- Data Management
- Infectious Diseases
- Clinical Research
- Health Services Research
- Registries
- Medicine
- Outcomes Research
- Clinical Trials
- Epidemiology
- Drug Safety
- Health Economics
- Sas
- Data Analysis
- Observational Studies
- Public Health
- Clinical Study Design
- Statistics
- Healthcare
- Team Leadership
- Project Management
- Statistical Programming
- Medical Writing
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