COVID-19 Vaccines, Medical Evidence Strategy Lead

 ROLE SUMMARY

The individual filling this position will assume the role of the Global Medical Evidence Strategy Lead within the COVID-19 vaccine franchise and will assume primary responsibility for overseeing the direction of and supporting strategy for COVID-19 medical evidence generation and interpretation; to include but not limited to COVID-19 diseases burden and vaccine effectiveness and other real-world COVID-19/SARS-CoV-2 epidemiologic studies. This position has a global remit and includes supporting and collaborating with all regional medical teams. The position is responsible for helping to develop and oversee an integrated global evidence strategy, in collaboration with BioNTech, to inform regulatory submissions, vaccine recommendations, label expansions and commercial decisions, while ensuring consistent methodologic rigor across studies and geographies. This position will work with leadership within Vaccines Medical Affairs to help develop and oversee execution of strategic goals for the COVID-19 vaccine program and use best practices in epidemiologic methods.

 

ROLE RESPONSIBILITIES

This role will work with the Global Medical Lead for Seasonal and Pipeline Viral Vaccines in the oversight of medical evidence strategy, including but not limited to COVID-19 disease burden vaccine effectiveness and other COVID-19/SARS-CoV-2 real-world epidemiologic studies. The role will:

• Ensure COVID-19 studies are appropriately conducted and prioritized in the context of the most current information on COVID-19 disease and best practices in epidemiologic methods and work with the Global Medical Lead for Seasonal and Pipeline Viral Vaccines to ensure alignment with strategic goals of the program
• Work with cross-functional teams to ensure post-authorization epidemiology studies are appropriately designed to address COVID-19 vaccine indications, including assessments of post-licensure COVID-19 vaccine effectiveness
• Ensure methods and outcomes are harmonized across the COVID-19 vaccine franchise
• Provide deep expertise on vaccine safety and risk/benefit assessments, primarily within the context of COVID-19 vaccine studies
• Work with the Global Medical Lead for Seasonal and Pipeline Viral Vaccines to ensure all regulatory considerations for COVID-19 vaccine effectiveness studies are incorporated and addressed in regulatory interactions
• Provide tactical oversight and coordination of COVID-19 epidemiology and vaccine effectiveness studies, with a primary focus on maintaining timely and methodologically rigorous execution across the portfolio
• Serve as lead or integral member of key study teams and committees
• Work with the Global Medical Lead and other team members within the Seasonal and Pipeline Viral Vaccines unit of Global Medical Affairs to provide relevant inputs for other assets and direction in epidemiologic methods and outputs
• Work across functions on the design, development and review of COVID-19 studies based on deep expertise in epidemiologic methods and respiratory pathogens and in alignment with the overall portfolio strategy
• S erve as an integral subject matter expert in supporting identification, establishment and maintenance of relationships with external partners collaborating on high priority global studies
• Oversee key facets of study design (e.g., methodology, protocols, analytic plans) for high priority epidemiologic and other scientific studies
• Provide key inputs for other functions as they pertain to COVID-19 diagnostics, COVID-19 vaccine development and COVID-19 commercial considerations
• Assist and advise in trouble shooting key scientific/epidemiologic issues study implementation, with travel to study sites as appropriate
• Work with internal and external experts to publish data in peer-reviewed manuscripts and, as needed, take the lead in authoring or overseeing the writing of manuscripts
• Work with internal and external experts, along with Global Medical Lead of Seasonal and Pipeline Viral Vaccines  to support setting strategy for abstract submission and presentation for scientific congresses in coordination with plans for engaging key opinion leaders and medical education
• Work with Global Medical Lead of Seasonal and Pipeline Viral Vaccines in supporting strategy regarding the collection and analysis of epidemiologic and other scientific data to drive the indications for the vaccine label and recommendations
• Lead the authoring, or oversee initial writing, of original manuscripts each year (i.e. conceptual manuscripts, position manuscripts, systematic reviews)
• Coordinate with leadership and with operational support, for supporting the development and tracking the budget for COVID-19 evidence generation study activities
• Provide strategic guidance on processes for systematic collation of published epidemiologic evidence to support regulatory submissions and decision making by vaccine recommendation normative bodies
• Oversee the use, maintenance and updates of internal surveillance dashboards and vaccine effectiveness trackers to support key functions and query responses

BASIC QUALIFICATIONS

• PhD with expertise in analytic epidemiology and experience with vaccine database (ie surveillance, safety, effectiveness) analyses.
• At least 5+ years of experience in vaccine-related or epidemiologic topical areas related to medical/scientific activities including research, clinical development, epidemiology, safety monitoring or immunization programs.
• Relevant experience can be in pharmaceutical, academic and/or medical or public health environments
• If do not hold a PhD, MPH or another relevant Master’s degree with 7+ years experience with similar requirements as previously stated.
• Recognized as a credible expert in epidemiologic analyses of vaccine or other medical product data, both internally and externally, supported by evidence from one or more of the following:
  • Lead or senior author of ≥ 5 peer-reviewed publications or book chapters.
  • Lead investigator for ≥ 2 major projects.
• Experience in respiratory pathogen epidemiology and population-based epidemiologic studies.
• Previous COVID-19 work experience preferred but not required.
• Demonstrated experience of working within a matrixed team.
• Demonstrated ability to lead across diverse cultures and geographies.
• Cross-functional leadership experience. 
• Demonstrated ability to manage projects to completion.
• Demonstrated record of advancing epidemiologic projects from conception through completion (to include study design, protocol and analytic plan development, operational implementation, data analysis, interpretation and reporting).
• Facility with reviewing, evaluating, interpreting and presenting complex data on safety and effectiveness of COVID-19 vaccines.
• Understand the critical data elements related to assessing the public health value of COVID-19 and seasonal vaccines, with an ability to oversee or conduct public health analyses of COVID-19 vaccine impact.
• Facility with interpreting data and identifying limitations for both Pfizer and competitor vaccines.
• Proficiency with MS-Office software (ie Word, Excel, Outlook, Teams, PowerPoint).
• Familiarity and some experience with using AI platforms that are integrated with work streams.
• Excellent verbal and written communication skills including scientific writing (lead authorship of ≥ 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 work within accelerated timelines.
• Willingness to travel (up to 15% may be required)

• Fluent in English writing, reading, speaking.

 

 

PREFERRED QUALIFICATIONS

• Experience overseeing post-authorization epidemiologic studies.
• Experience with adverse events assessments as part of vaccine effectiveness studies.
• Experience with regulatory agency interactions.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Travel up to 15%

Work Location Assignment: Hybrid

The annual base salary for this position ranges from $176,600.00 to $294,300.00. 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. This role is posted in multiple locations. If you are applying for the role in an secondary job posting location where pay transparency regulations apply, your Talent Advisor will share the local pay information with you during the first interview.

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   disabilityrecruitment@pfizer.com . 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.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on  Pfizer Careers .

Medical