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.
  • Principal or lead investigator for at least two major projects.
  • Presenting author for at least 5 abstracts at international scientific congresses
• Specific expertise in adult RSV epidemiology and vaccine effectiveness studies
• 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 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 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 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 15% may be required)

• 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

• Direct experience overseeing post-authorization efficacy studies
• Experience with adverse events assessments as part of vaccine effectiveness studies

ORGANIZATIONAL RELATIONSHIPS
• Managerially, reports directly to the Team Lead, Medical Affairs, Adult RSV Vaccine Program; technically coordinates with RSV evidence generation staff scientific affairs.
• Participates at the global level with other colleagues in RSV vaccine program on issues of importance to global RSV epidemiology and vaccinology, with an emphasis on issues of relevance to RSV vaccine licensure, recommendations, and use.
• Coordinates activities with others working on RSV adult evidence generation including clinical scientists and medical evidence generation lead.
• Works closely with Pfizer country medical staff globally to ensure that studies are aligned with scientific, public health, and medical goals for adult RSV vaccines.
• Works with RSV KOLs globally
Define data gaps globally that will impede decision-making related to RSV vaccine use, (including pre- and post-licensure), prioritizing these gaps, and developing and implementing solutions to close these gaps.
No direct supervisory responsibility
PHYSICAL/MENTAL REQUIREMENTS
No specific physical or mental requirements
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Travel approximately 15% (up to 20%)
Work Location Assignment: This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week or more as needed.
The annual base salary for this position ranges from $254,100.00 to $423,500.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 25.0% 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.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
Sunshine Act
Pfizer 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 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.
Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email [email protected] . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
Medical