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

Company: Pfizer
Location: New York
Posted on: November 26, 2022

Job Description:

ROLE SUMMARYPfizer's RSVPreF vaccine recently announced positive top line results in a phase III trial of maternal immunization for the prevention of respiratory syncytial virus in infants. The company is preparing to launch for a maternal indication, and as such, additional global scientific affairs colleagues are needed.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 field-based prospective epidemiology studies as well as 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, though initial activities may focus on North America, Europe and other IDM countries expected to be among the first to launch RSVpreF (e.g., Australia). 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 RSVpreF vaccine in pediatric populations, as well as other maternal assets in development and under the Global Respiratory Vaccines and Antivirals team, especially Pfizer's candidate group B streptococcus (GBS) vaccine.The most urgent need will be to design and implement studies in anticipation of regulatory approval, including post-licensure epidemiologic studies, both field-based, prospective studies and retrospective, prospective, and cross-sectional secondary data analyses. Modeling studies may also be in scope. 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 RSVpreF. This would include studies to assess direct and indirect RSVpreF 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.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, seroepidemiology, 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's country medical staff in North America and key international developed markets and emerging markets colleagues as well as those 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).This position will participate in regulatory strategies including preparation for VCLT discussions, scientific revision to critical reports and medical documents for regulatory submissions. The position will be supported by a Clinical Affairs team that has 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 is a high-level position that 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.ROLE RESPONSIBILITIES

  • Under the supervision of the Global Medical Lead for Respiratory Vaccines and Antivirals, and along with other Scientific Affairs colleagues, lead development of field-based epidemiology and other science related to maternal RSV vaccine, public health decision-making and vaccine implementation primarily in North America and Europe:
    • Act as a lead resource for ensuring integration of epidemiologic information and other scientific information (disease burden, public health value, etc.) for the maternal RSV vaccine asset
    • Act as a lead resource for overseeing and coordinating epidemiologic and other scientific activities related to RSV vaccine ensuring integration of this information into the overall RSV development program
    • Define data gaps in target areas
    • Define epidemiology and other scientific research and data priorities
    • Lead field epidemiology studies across multiple countries and sites involving primary data collection
    • Lead epidemiology studies involving secondary analyses of real-world data including systematic literature reviews and metanalyses.
    • Oversee 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 - primarily epidemiologic - 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.
    • Provide expertise on vaccine safety concerns
    • Work with Epidemiology experts within Vaccines MDSCA and Emerging Markets 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
      • Work with the Global Medical Lead to define positions on global issues related to the epidemiology and other science of RSV vaccines and take the lead for publishing these positions.
      • Act as scientific/epidemiology point of contact for 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
      • Accountable for the collection of epidemiologic and other scientific data in target regions necessary for developing 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).
      • 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.
      • Participate in the Respiratory Vaccine Leadership Team meetingBASIC 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.
        • Medical degree (MD), PhD, or DrPH with experience and expertise in vaccinology, ideally including maternal immunization, field-based epidemiology, and secondary data analysis.
        • At least 10 years of experience in vaccine- or vaccine-preventable disease related medical/scientific activities including research, clinical development, applied epidemiology, and immunization programs.
        • Specific experience 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) in both high resource settings and LMICs
        • Specific 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 studying rare outcomes, and pregnancy-related, fetal or neonatal outcomes and experience working with pregnancy registry data highly desirable
        • Experience leading systematic literature reviews and metanalyses
        • Recognized expert in vaccines or RSV to be credible both internally and externally as evidenced by two or more of the following:
          • Lead or senior author of at least 10 peer-reviewed publications or book chapters, of which at least 5 should pertain directly to RSV or maternal immunization
          • Principle or lead investigator for at least two major epidemiology studies with published results, at least one of which pertains to RSV
          • Principle or lead investigator for at least two large secondary data analyses pertaining to vaccination in pregnancy, respiratory syncytial virus, or assessments of maternal, fetal or neonatal outcomes
          • Presenting author for at least 5 abstracts at international scientific congresses, at least 3 of which pertain to maternal immunization or RSV
          • Recognized as an established RSV and/or maternal immunization KOL within the vaccine field as evidenced by participation in working groups, technical advisory groups, or meetings of KOLs organized by key immunization players such as BMGF, Gavi, WHO. -
            • Proven ability to interact with KOLs and government officials dealing with immunization programs/vaccine policy and vaccine recommendations at the highest levels.
            • Demonstrated experience with participating in a matrixed team.
            • Demonstrated ability to lead across diverse cultures and geographies.
            • Significant cross-functional leadership experience. -
            • Previous work experience on RSV disease or vaccines
            • Documented ability to manage projects to completion.
            • 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; understand the emerging safety and efficacy profile of Pfizer RSV vaccines
            • 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 lead authorship in at least 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 within timelines.
            • Willingness to travel (approximately 20% may be required)
            • Fluent in English writing, reading, speakingPREFERRED 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
              • Recognized as an established RSV and/or maternal immunization KOL within the vaccine field
              • Ongoing relationships with other RSV KOLs and RSV experts at academic institutions
              • Experience with maternal and perinatal epidemiology and conducting vaccine impact studies
              • Knowledge of the commercial and global public health issues that drive respiratory vaccine development projects
              • Ability to conduct independent data analyses and familiarity with a least one statistical software program (SPSS, 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 Travel approximately 20% as allowable by COVID restrictionsOther Job Details:Last Date to Apply for Job: November 30th, 2022Additional Location Information: US, Europe, CanadaEligible for Relocation Package: No#LI-PFEFor roles based in New York City: The annual base salary for this position ranges from $191,800.00 to $319,700.00. In addition, this position offers an annual bonus with a target of 25.0% of the base salary and eligibility to participate in our share based long term incentive program. Benefits offered include a retirement savings plan, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.Relocation assistance may be available based on business needs and/or eligibility.Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. - As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine ActPfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. - These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. - Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. - Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. - If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.EEO & Employment EligibilityPfizer 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.Medical#LI-PFE

Keywords: Pfizer, New York , Sr. Director, Scientific Affairs, Maternal RSV Vaccines, Global Respiratory Vaccines and Antivirals, Executive , New York, New York

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