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-based epidemiology and other science related to maternal RSV vaccine, public health decision-making and vaccine implementation:

• Define data gaps in target areas

• Define epidemiology and other scientific research and data priorities

• Contribute to and lead field epidemiology studies across multiple countries and sites involving primary data collection

• Contribute to and lead epidemiology studies involving secondary analyses of real-world data including systematic literature reviews and metanalyses.

• Contribute to the development of common strategies across study sites within the target regions and globally, including common protocols, case report forms, and databases

• Develop innovative approaches to answering global questions related to RSV disease as they apply to maternal RSV vaccines

• Identify, establish, and maintain relationships with external partners that can collaborate with high priority global studies

• Provide input to all aspects of study design (e.g., methodology, protocols, analytic plans) for high priority epidemiologic and other scientific studies of importance for maternal RSV vaccine issues such as Vaccine Technical Committee recommendations, schedules, public payer options, relative value compared to other vaccines or preventive interventions

• Assist with development of clinical case definitions, enrollment criteria, defining catchment areas and denominator populations, and clinical decision- making algorithms for studies globally as part of the broader respiratory vaccines team.

• Work with Epidemiology experts within the global, regional and country Vaccines Teams to develop studies for post-licensure RSV vaccine effectiveness

• Provide input into generic epidemiology study designs that will be used globally for RSV vaccine studies (e.g., surveillance methods; use of different diagnostic approaches and molecular methods)

• 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 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.

• Work with internal and external experts to develop abstracts and present data for scientific congresses, including taking the lead for writing and presenting

• Identify key topics appropriate for advisory boards related to adult RSV vaccine issues (e.g., schedules, laboratory evaluation, carriage and transmission, public health burden)

• Assist the global RSV medical affairs team with developing various resources for internal use on the epidemiology and vaccine science related to RSV vaccines

• Respond to scientific questions related to RSV vaccine commercial, regulatory, and policy issues and provide information/data to support internal staff working on commercial, regulatory, and medical affairs planning

• Participate in the Epidemiology Sub-committee (ESC) and Medical Scientific Committee, both of which review external study proposals, as well as the publication-related committees.

BASIC QUALIFICATIONS

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.

• PhD in infectious disease epidemiology or vaccinology (ideally including expertise in maternal immunization, field-based epidemiology, and secondary data analysis) or closely related field with at least 6 years of experience in infectious disease, (ideally vaccine- or vaccine-preventable disease) related scientific activities including research, clinical development, applied epidemiology, and immunization programs.

• Expertise designing and implementing field-based epidemiology studies such as prospective infectious disease surveillance studies and assessments of real-world vaccine effectiveness (e.g., test negative design studies, case control, prospective cohort, household transmission) ideally in both high resource settings and LMICs, and in diverse populations

• Experience designing and implementing secondary data analyses in large, complex data sources (e.g., algorithm-based analysis of claims and EHR data, integrated health care network data)

• Experience with systematic literature reviews and metanalyses

• Track-record of publications related to infectious diseases or vaccines, and ideally maternal immunization and/or RSV or other respiratory viruses affecting pediatric populations

• Proven ability to interact with KOLs, government officials, and other stakeholders on immunization programs/vaccine policy and vaccine recommendations.

• Demonstrated experience with participating in a matrixed team.

• Demonstrated ability to work across diverse cultures and geographies.

• Ability to identify innovative solutions and work through internal processes and procedures to enhance the utility of real-world data

• Documented ability to take a relevant vaccine or vaccine-preventable disease epidemiology project from start to end including conception, design, protocol and analytic plan development, implementation, analysis, and reporting and interpretation of results.

• Ability to understand subtle issues related to RSV vaccinology and epidemiology, especially maternal immunization

• Able to review, evaluate, interpret, and present complex data to internal and external audiences

• Understand the critical data elements related to assessing the public health value of RSV vaccines, ability to oversee or conduct public health analyses of RSV vaccine impact, and ability to interpret data and data limitations for both Pfizer and competitor RSV prevention products.

• Proficiency with MS-Office software (Word, Excel, PowerPoint)

• Excellent verbal and written communication skills including scientific writing skills as evidenced by co-authorship of at least 20 peer-reviewed publications in English, including at least 5 first author publications

• 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 within timelines.

• Willingness to travel (approximately 20% may be required)

• Fluent in English writing, reading, speaking

PREFERRED QUALIFICATIONS

• Knowledge of (and ideally experience working directly with or for) immunization programs/experts at international agencies relevant to global immunization including CDC, BMGF, PATH, Gavi, WHO, or UNICEF

• Experience with modeling (e.g., health economic modeling) and evaluation of vaccine impact highly desirable

• Experience with maternal and perinatal epidemiology and conducting vaccine impact studies

• Ability to conduct independent data analyses and familiarity with a least one statistical software program (SAS, Stata, R, etc.) (note that independent data analysis will not be part of the position's role but experience conducting statistical analyses of epi studies highly desirable)

• Experience writing SOPs, developing CRFs, and building databases for primary data collection, as well as training site staff and troubleshooting implementation on ongoing multi-site studies

• Multiple languages a plus but not required.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Last Date to Apply for Job:August 13, 2024

This is a hybrid in-office role requiring 2-3 days on-site per week

Eligible for Relocation Package: No

The annual base salary for this position ranges from $161,600.00 to $269,400.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

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

Sunshine Act

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EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.

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