COVID-19 Vaccines, Medical Evidence Strategy Lead – Sr. Director

• Oversee strategy for COVID-19 medical evidence generation and interpretation, including vaccine effectiveness and COVID-19/SARS-CoV-2 burden studies
• Support and collaborate with regional medical teams globally
• Prioritize Comirnaty indications across licensed populations and countries
• Set strategy for real-world evidence generation with Pfizer and BioNTech
• Ensure studies meet scientific rigor, operational efficiency, regulatory requirements and public health needs
• Set strategic goals for the COVID-19 vaccine program using epidemiologic best practices
• Lead oversight of medical evidence strategy and post-authorization epidemiology studies
• Design and harmonize methods, outcomes, protocols, case report forms and databases across studies
• Incorporate regulatory considerations into vaccine effectiveness studies and regulatory interactions
• Provide technical oversight and coordinate epidemiology and vaccine effectiveness studies
• Serve as lead or integral member of key study teams and committees
• Establish and maintain relationships with external partners for high-priority global studies
• Oversee study methodology, protocols and analytic plans
• Provide vaccine safety expertise and inputs on diagnostics, vaccine development and commercial considerations
• Troubleshoot scientific and epidemiologic issues, including travel to study sites as appropriate
• Analyze and interpret study data with internal and external statistics and data-analysis experts
• Lead or oversee peer-reviewed manuscripts, abstracts and scientific congress presentations
• Develop evidence strategy to support vaccine labeling and recommendations
• Develop and track COVID-19 study budgets
• Collate published epidemiologic evidence for regulatory submissions and vaccine recommendation bodies
• Oversee internal surveillance dashboards and vaccine effectiveness trackers

• PhD with expertise in analytic epidemiology and experience with vaccinology
• At least 10 years of experience in vaccine-related or vaccine-preventable disease medical/scientific activities
• Recognized expertise in vaccines and viral respiratory disease
• Lead or senior author of at least 5 peer-reviewed publications or book chapters, or principal/lead investigator for at least 2 major projects
• Expertise in respiratory pathogen epidemiology and population-based vaccine studies
• Experience working within a matrixed team
• Ability to lead across diverse cultures and geographies
• Substantial cross-functional leadership experience
• Ability to manage projects to completion
• Experience advancing vaccine-preventable disease epidemiologic projects from conception through completion
• Ability to design studies, develop protocols and analytic plans, implement operations, analyze data, interpret results and report findings
• Facility with reviewing, evaluating, interpreting and presenting complex COVID-19 vaccine safety and effectiveness data
• Understanding of data elements used to assess public health value and vaccine impact
• Ability to interpret data and identify limitations for Pfizer and competitor vaccines
• Proficiency with MS Office software including Word, Excel, Outlook, Teams and Power Point
• Familiarity and some experience using AI platforms integrated with work streams
• Excellent verbal and written communication skills, including scientific writing
• Lead authorship of at least 5 peer-reviewed publications in English
• Strong interpersonal skills and ability to influence through others
• Proven ability to build relationships with cross-functional stakeholders
• Strong work ethic and record of delivering high-quality work within accelerated timelines
• Willingness to travel up to 15%
• Fluent in English writing, reading and speaking
• Permanent work authorization in the United States
• U.S. work visa sponsorship is not available
• Preferred: experience overseeing post-authorization effectiveness studies
• Preferred: experience with adverse event assessments in vaccine effectiveness studies
• Preferred: experience with regulatory agency interactions

Demonstrates expertise in analytic epidemiology and vaccinology, with a strong focus on COVID-19 vaccine effectiveness and safety studies. Proven ability to lead cross-functional teams, design and…