Experience

Novavax

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Vice President, Safety Epidemiology and Benefit Risk

  • Nov 2021 - Present

  Built and now lead the safety epidemiology group to support the COVID-19 and other vaccine programs. Our team leads a number of studies and works cross-functionally to develop evidence that supports the post-licensure environment of the COVID-19 vaccine program. Built and now lead the safety epidemiology group to support the COVID-19 and other vaccine programs. Our team leads a number of studies and works cross-functionally to develop evidence that supports the post-licensure environment of the COVID-19 vaccine program.



Merck

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Executive Director, Epidemiology Department, Center for Observational and Real-World Evidence

  • Aug 2012 - Nov 2021

  Vaccine and Drug Development Programs - Post-licensure safety / effectiveness studies to support regulatory and commercial objectives - Develop and execute epidemiology strategies to support regulatory approvals (FDA / EMA) - Extensive experience with data science and large datasets - Develop and deliver evidence to support product value - Design and conduct global primary data collection studies to communicate disease burden - Develop quality of life assessments and… Show more Vaccine and Drug Development Programs - Post-licensure safety / effectiveness studies to support regulatory and commercial objectives - Develop and execute epidemiology strategies to support regulatory approvals (FDA / EMA) - Extensive experience with data science and large datasets - Develop and deliver evidence to support product value - Design and conduct global primary data collection studies to communicate disease burden - Develop quality of life assessments and Patient Reported Outcome instruments - Validation of measurements - Manage a group of professional scientists - Drug development: HIV, HCV, CMV, C. difficile, antibiotics, antifungals - Vaccine development: Rotavirus, HPV, HIV, Pertussis

• Director & Area Lead for Infectious Disease

  • Feb 2010 - Aug 2012

• Associate Director, Epidemiology Department

  • Jul 2007 - Feb 2010

  Lead epidemiologist for several vaccine programs (e.g., Rotavirus, HPV, HIV and others). Developed and successfully led large research programs to demonstrate unmet medical need, suport clinical development and FDA / EMA post-marketing commitments.

• Sr. Epidemiologist

  • Aug 2004 - Jun 2007

  Lead epidemiologist for the rotavirus vaccine program. Planned and executed multiple global studies that supported successful licensure and launch of the RotaTeq vaccine. Initiated and successfully delivered post-marketing studies to demonstrate the safety and effectiveness of the rotavirus vaccine in multiple regions. Conducted large scale demonstration project in Nicaragua to accelerate vaccine access in less developed regions.

• Epidemiologist

  • Sep 2000 - Jul 2004