Director, Scientific Affairs, Maternal RSV Vaccines, Global Respiratory Vaccines and Antivirals

ROLE SUMMARY

Pfizer’s respiratory syncytial virus (RSV) vaccine, ABRYSVO, was approved by the FDA and EMA in 2023 and is the only licensed vaccine for the prevention of RSV in infants via maternal immunization. As ABRYSVO is rapidly launched in additional countries around the world, global scientific affairs colleagues are needed to support studies of RSV epidemiology and vaccine effectiveness.

The individual in this position will assume a global role within the MDSCA respiratory vaccines asset, with a focus and direct responsibility for scientific work – particularly to design, implement and oversee vaccine effectiveness studies, including prospective studies and impact analyses leveraging secondary data (e.g., claims, electronic health records, integrated health care system data) – for the maternal RSV vaccine asset. This position is global; initial activities may focus on North America, Latin America, Europe and other countries expected to be among the first to launch RSVpreF. In time, providing support to studies in LMICs may also be in scope. RSV maternal-related activities will be the priority, though there may also be work pertaining to the use of respiratory viral vaccines in pediatric populations.

The most urgent need will be to design and implement real-world post-licensure studies of RSV epidemiology and vaccine effectiveness. Both primary and secondary data studies are in scope, and may include retrospective, prospective or cross-sectional designs, as well as modeling efforts. The studies to be designed and led by the individual in this position will include post licensure commitments, studies to support the reinforcement or expansion of the vaccine’s label as well as studies to inform VTC recommendations for use of ABRYSVO. This would include studies to assess direct and indirect vaccine effectiveness (VE) and impact across age groups, risk groups, and geographies, and studies to support uptake of the vaccine and access/equity around the globe.

ROLE RESPONSIBILITIES

As part of the studies outlined above, the individual in this position will be responsible for designing assessments of disease burden among various age groups (infant, pediatric and maternal) and risk populations (e.g., due to underlying conditions, SES, gestational age at birth, etc.), risk factors for severe disease, short and long term sequalae including secondary infections as well as recurrent wheeze and asthma, and vaccine impact on bacterial/viral co-infections, all-cause respiratory outcomes and overall infant/child health, including assessment of any impact on maternal, fetal or neonatal outcomes and how VE is impacted by gestational age at both vaccination and birth. Assessments of geographic and temporal variability of both disease rates and VE will also be critical. Other topics may include studies of indirect effects and household transmission, systems serology, sero-epidemiology, and impact modeling.

The position will have responsibility for overseeing and ensuring the scientific success of epidemiologic and other studies related to maternal RSV by working with other members of the Scientific Affairs team, Pfizer country medical teams, and colleagues in Global Medical Affairs, Vaccine Research and Development, Regulatory, Commercial, Public Affairs, and Health Economics and Outcomes Research. Using epidemiologic expertise, the position will provide input into critical aspects of study design such as case and outcome definitions, enrollment criteria, defining catchment areas and denominator populations, and algorithm-based exposure and outcome determination. The position will work extensively with external partners – such as academic centers of excellence, VTCs, Ministry of Health representatives and KOLs – to provide input at all phases of studies (concept, design, protocol, assessment of implementation, interpretation, presentation and publication of results).The position will work closely with colleagues in complimentary teams that have responsibility for study implementation, budget management and tracking, contracting, and statistics/analysis to ensure implementation success.

A key requirement of this position is expertise and interest in publishing study results in peer-reviewed journals. This position requires skill and experience with field epidemiology, complex data analyses, managing the scientific aspects of complicated long-term projects, interacting with world experts on RSV disease, maternal immunization, and vaccines, experience operating in varied cultural settings, and integrating within a multi-disciplinary team at Pfizer.

• Under the supervision of the Global Scientific Affairs and Epidemiology Lead for RSV Maternal and Pediatric Vaccines, and along with other epidemiologists RSV Maternal Scientific Affairs group, this individual will lead and contribute to the development of field-base