ROLE SUMMARY

The individual filling this position will assume the role of the Global Medical Evidence Strategy Lead within the COVID-19 vaccine franchise and will assume primary responsibility for overseeing the strategy for COVID-19 medical evidence generation and interpretation; to include but not limited to vaccine effectiveness and COVID-19/SARS-CoV-2 burden studies. This position has a global remit and includes support of and collaboration with all regional medical teams. The position will prioritize indications for Comirnaty in all populations and countries for whom and where it is licensed. The foremost priority will be in setting strategy for the generation of real-world evidence across Pfizer and in collaboration with BioNTech to ensure COVID-19 studies are conducted with scientific rigor and operational efficiency in support of regulatory requirements, public health needs and education of and interactions with healthcare providers. This position will work with Vaccines leadership to set the strategic goals of the COVID-19 vaccine program and use best practices in epidemiologic methods.

ROLE RESPONSIBILITIES

This role will be the primary lead for oversight of medical evidence strategy, including but not limited to COVID-19 vaccine effectiveness and COVID-19/SARS-CoV-2 burden studies. The role will:

• Ensure COVID-19 studies are conducted appropriately in the context of most current information on COVID-19 disease, strategic goals of the program and best practices in epidemiologic methods.
• Work with cross-functional teams to ensure post-authorization epidemiology studies are appropriately designed to address COVID-19 vaccine indications, including assessments of post-licensure COVID-19 vaccine effectiveness.
• Ensure methods and outcomes are harmonized across COVID-19 vaccine franchise.
• Ensure all regulatory considerations for COVID-19 vaccine effectiveness studies are incorporated and addressed in regulatory interactions.
• Provide technical oversight and coordination of COVID-19 epidemiology and vaccine effectiveness studies, with a primary focus on maintaining consistency of overall strategy across the portfolio.
• Serve as lead or integral member of key study teams and committees.
• Work with other team members within the Seasonal and Pipeline Viral Vaccines unit of Global Medical Affairs to provide relevant inputs for other assets and direction in epidemiologic methods and outputs.
• Work with other functions on the design COVID-19 studies based on deep expertise in epidemiologic methods and respiratory pathogens.
• Oversee the development of common strategies across studies and study sites, including common protocols, case report forms, and databases, as indicated.
• Identify, establish, and maintain relationships with external partners collaborating on high-priority global studies.
• Oversee key facets of study design (e.g., methodology, protocols, analytic plans) for high priority epidemiologic and other scientific studies.
• Provide expertise on vaccine safety concerns, primarily within context COVID-19 vaccine studies
• Provide key inputs for other functions as they pertain to COVID-19 diagnostics, COVID-19 vaccine development and COVID-19 commercial considerations.
• Assist and advise in trouble shooting key scientific/epidemiologic issues study implementation, with travel to study sites as appropriate.
• Work with internal and external experts in statistics and data analysis to analyze and interpret data from key COVID-19 vaccine and burden studies.
• Work with internal and external experts to publish data in peer-reviewed manuscripts, and as needed, take the lead in authoring or overseeing the writing of the first draft of manuscripts.
• Work with internal and external experts to develop abstracts and present data for scientific congresses, including taking the lead for writing and presenting as needed.
• Develop strategy regarding the collection and analysis of epidemiologic and other scientific data to drive the indications for the vaccine label and recommendations.
• Lead the authoring, or oversee initial writing, of original manuscripts each year (i.e. conceptual manuscripts, position manuscripts, systematic reviews, or where appropriate manuscripts based on original data).
• Assume responsibility, in coordination with leadership and with operational support, for developing and tracking the budget for Covid studies.
• Lead the systematic collation of published epidemiologic evidence to support regulatory submissions and decision making by vaccine recommendation normative bodies.
• Oversee the use, maintenance and updates of internal surveillance dashboards and vaccine effectiveness trackers to support key functions and query responses.

BASIC QUALIFICATIONS

• PhD with expertise in analytic epidemiology and experience with vaccinology.
• At least 10 years of experience in vaccine-related or vaccine-preventable disease related to medical/scientific activities including research, clinical development, epidemiology and immunization programs.
• Recognized as a credible expert in vaccines and viral respiratory disease, both internally and externally, supported by evidence from one or more of the following:
  • Lead or senior author of 6gt;= 5 peer-reviewed publications or book chapters.
  • Principal/lead investigator for 6gt;= 2 major projects.
• Expertise in respiratory pathogen epidemiology and population-based vaccine studies.
• Previous COVID-19 work experience preferred but not required.
• Demonstrated experience of working within a matrixed team.
• Demonstrated ability to lead across diverse cultures and geographies.
• Substantial cross-functional leadership experience.
• Demonstrated ability to manage projects to completion.
• Demonstrated record of advancing vaccine-preventable disease epidemiologic project from conception through completion (to include study design, protocol and analytic plan development, operational implementation, data analysis, interpretation and reporting).
• Facility with reviewing, evaluating, interpreting and presenting complex data on safety and effectiveness of COVID-19 vaccines.
• Understand the critical data elements related to assessing the public health value of COVID-19 and seasonal vaccines, with an ability to oversee or conduct public health analyses of COVID-19 vaccine impact.
• Facility with interpreting data and identifying limitations for both Pfizer and competitor vaccines.
• Proficiency with MS-Office software (ie Word, Excel, Outlook, Teams, PowerPoint).
• Familiarity and some experience with using AI platforms that were integrated with work streams.
• Excellent verbal and written communication skills including scientific writing (lead authorship of 6gt;= 5 peer-reviewed publications in English).
• Strong interpersonal skills.
• Proven ability to influence and succeed through others and to form excellent relationships with key cross-functional stakeholders.
• Demonstrated strong work ethic, and proven track record of delivering high quality work within accelerated timelines.
• Willingness to travel (up to 15% may be required)
• Fluent in English writing, reading, speaking.

PREFERRED QUALIFICATIONS

• Experience overseeing post-authorization effectiveness studies.
• Experience with adverse events assessments as part of vaccine effectiveness studies.
• Experience with regulatory agency interactions.
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Travel up to 15%

Work Location Assignment:Hybrid

#LI-PFE

Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.