Senior Director, Adult RSV Vaccine Medical Evidence Strategy Lead (MD position)

ROLE SUMMARY

This position will assume a global role within the RSV adult vaccines asset, with a focus and direct responsibility for RSV adult vaccine program medical evidence strategy, including RSV vaccine effectiveness and burden studies. This position has a worldwide focus and will include supporting work in Asia. The work will have as its first priority the adult indication of Pfizer’s RSV vaccine, RSVpreF. RSVpreF/Abrysvo is licensed in numerous countries globally in adults.

The most urgent need will be coordinating evidence generation work across Pfizer to ensure RSV adult studies are conducted appropriately in context of latest information on RSV disease, strategic goals of the vaccine program, and best practices in epidemiological methods. The role also oversees regulatory interactions related to Abrysvo vaccine effectiveness studies in adults.

ROLE RESPONSIBILITIES

Under the supervision of the Team Lead, Medical Affairs, Adult RSV Vaccine Program, take the primary lead for oversight of medical evidence strategy, including RSV vaccine effectiveness and burden studies:

• Ensure RSV adult studies are conducted appropriately in context of latest information on RSV disease, strategic goals of the program, and best practices in epidemiological methods.
• Design post-authorization epidemiology studies for RSV adult indication including assessments of post-licensure adult RSV vaccine effectiveness.
• Ensure methods and outcomes are harmonized across RSV adult evidence generation portfolio.
• Ensure all regulatory feedback on RSV adult VE studies is considered in future regulatory interactions.
• Execution of studies is done by another group within Pfizer, but role will provide technical oversight and coordination for those executing the studies to ensure design and strategic consistency across portfolio and be member of key study teams.
• Provide input on RSV adult study design and execution based on deep expertise in RSV disease and epidemiologic methods.
• 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 that can collaborate with high priority global studies.
• Oversee aspects of study design (e.g., methodology, protocols, analytic plans) for high priority epidemiologic and other scientific studies.
• Provide expertise on vaccine safety concerns within context of RSV adult vaccine studies.
• Provide expertise in RSV diagnostics.
• Assist with trouble shooting major scientific/epidemiology issues during study implementation, including through travel to study sites when appropriate.
• Work with internal and external experts in statistics and data analysis to analyze and interpret data from key RSV vaccine and burden studies.
• Work with internal and external experts to publish data in peer-reviewed manuscripts, including taking the lead for writing the first draft of these manuscripts if needed.
• Work with internal and external experts to develop abstracts and present data for scientific congresses, including taking the lead for writing and presenting in some cases.
• Develop strategy regarding the collection of epidemiologic and other scientific data in target regions necessary for enhancing RSV vaccine product labels.
• Take the lead in writing original manuscripts each year (such as conceptual manuscripts, position manuscripts, systematic reviews, or where appropriate manuscripts based on original data). 

BASIC QUALIFICATIONS

• MD degree with expertise in vaccinology and field-based and analytic epidemiology

• At least 10 years of experience in vaccine-related or vaccine-preventable disease related medical/scientific activities including research, clinical development, epidemiological, and immunization programs.

• Recognized expert in vaccines and viral respiratory disease to be credible both internally and externally as evidenced by one or more of the following:

  • Lead or senior author of at least 5 peer-reviewed publications or book chapters.