Global Respiratory Vaccines, Scientific Affairs and Epidemiology Lead for Adult RSV Vaccines

Employer
Pfizer
Location
Collegeville, Pennsylvania
Salary
Competitive
Posted
Jul 20, 2021
Closes
Jul 31, 2021
Ref
556106
Jobseeker Type
Professional
Organization Type
Corporate
Hours
Full Time
This position will assume a leadership and global role within the MDSCA respiratory vaccines asset, with a focus and direct responsibility for scientific work - with a focus on field epidemiology - for RSV vaccines. This position is global but initially will focus on North America and Europe. Depending on time availability and need, work may also include supporting work in Asia or other areas of the world. The work will have as its first priority adult RSV vaccines. Depending on staffing and the rollout of pediatric RSV vaccines, additional work may involve this population. Because no adult RSV vaccine is currently licensed, the most urgent need will be to design and implement epidemiologic, field-based studies to support licensure of an adult RSV vaccine in North America and Europe, with an emphasis on burden of disease using linking of outpatient and inpatient disease, and novel laboratory methods. Additional studies may focus on risk factors for disease, sequalae and mortality, and age, geographic, and temporal variability. Other topics may include safety, transmission, and post-licensure vaccine effectiveness. A smaller portion of work may include genomics, immunogenicity, immunology, and vaccine impact. The position will have responsibility for overseeing and ensuring the scientific success of epidemiologic and other studies related to adult RSV by working with Pfizer's North American team, the International Developed Markets team (who has responsibility for developed Asian countries), as well as colleagues in global medical affairs, vaccine research and development, regulatory, commercial, public affairs, and health economics and outcomes research and with country staff in specific target countries. Using medical expertise, the position will provide input into epidemiologic aspects of studies such as clinical case definitions, enrollment criteria, defining catchment areas and denominator populations, and clinical decision-making algorithms. The position will work extensively with external partners - such as Gavi, WHO, local government officials, and local researchers and epidemiology experts - 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 discussion, 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. This is a high-level position that requires skill and experience with field epidemiology, managing the scientific aspects of complicated long-term projects, interacting with world experts on RSV disease and vaccine, 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, take the primary lead for developing the field based epidemiology and other science related to adult RSV vaccine, public health decision-making and vaccine implementation primarily in North America and Europe:
    • Act as the lead resource for ensuring integration of epidemiologic information and other scientific information (carriage, disease burden, public health value, etc.) for the adult RSV vaccine asset
    • Act as the lead resource for overseeing and coordinating epidemiologic and other scientific activities related to RSV vaccine ensuring integration of this information into the overall adult RSV development program
    • Define data gaps in target areas
    • Define epidemiology and other scientific research and data priorities
    • Lead field epidemiology studies in the region involving primary data collection
    • Lead epidemiology studies in the region involving secondary analyses of real-world data.
    • 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 adult 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 adult RSV vaccine issues such as Vaccine Technical Committee recommendations, schedules, public payer options, relative value compared to other pneumococcal vaccines
    • 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 to study team on how treatment policies and algorithms, particularly those related to antibiotic use, may affect study design and interpretation.
    • Provide expertise on vaccine safety concerns
    • Work with Epidemiology experts within Vaccines MDSCA and Emerging Markets to develop studies for post-licensure adult 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 techniques such as chest x-rays; 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 pneumococcal 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 the initial 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 pneumococcal 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
  • Participate in the Respiratory Vaccine Leadership Team meeting


BASIC QUALIFICATIONS
  • Medical degree (MD), PhD, or DrPH with experience and expertise in vaccinology and field-based 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 or infectious diseases 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
    • Principle or lead investigator for at least two major projects
    • Presenting author for at least 5 abstracts at international scientific congresses
  • 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 considered a major plus but not required
  • 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, analytic plan, implementation, analysis, and reporting and interpretation of results.
  • Ability to understand subtle issues related to RSV vaccinology and epidemiology
  • 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 pneumococcal 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 vaccines.
  • Proficiency with MS-Office software (Word, Excel, Powerpoint)
  • Excellent verbal and written communication skills including scientific writing skills as evidence 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, although substantially less currently)
  • Fluent in English writing, reading, speaking
  • 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.


PREFERRED QUALIFICATIONS
  • Knowledge of immunization programs and groups such as Gavi/WHO, and an established network of KOLs within the vaccine field and relationships with established academic institutions
  • Knowledge of the commercial and environmental issues that drive pneumococcal 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)
  • Multiple languages a plus but not required.


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Travel up to 20% internationally

Other Job Details

Last Date to Apply for Job: August 2, 2021

Eligible for Relocation Package

Eligible for Employee Referral Bonus

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