COVID-19 Vaccines, Medical Evidence Strategy Lead - MD (Sr. Director)

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.

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