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Location

La Jolla, CA | United States

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Job description

ROLE SUMMARY

This position will assume a leadership and global role within the MDSCA Respiratory Vaccines and Antivirals group. Within this set of products, the incumbent will have direct responsibility for pipeline assets. The initial focus will be on RSV antivirals, specifically Sisunatovir, which is in phase 3 clinical development. Additional work will include pediatric and combination respiratory vaccines, with involvement dependent on advancement of these programs. As with other programs within the Respiratory Vaccines and Antivirals group, the position will have a global focus, covering all regions of the world, with a focus on North American and International Developed Markets.

The most urgent need will be to provide expert medical and epidemiological input and support to the clinical development program and other program/global medicine team activities, including clinical development programs studies and study designs, cost-effectiveness modelling, and design and implementation of a medical plan to support the clinical development program and eventual product launch. For the latter, the incumbent will design and conduct epidemiologic studies, which may include analyses of real-world data, literature reviews, and field studies with primary data collection. Studies may focus on disease burden and etiologic distribution/epidemiologic patterns, risk factors for severe disease, sequalae and mortality, transmission, and genomics. Field studies within our group usually are collaborative studies with established academic partners.

Using medical/epidemiological expertise, the position will oversee 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 researchers and epidemiology experts and internal Pfizer staff to oversee at all phases of studies (concept, design, protocol, assessment of implementation, interpretation, presentation, and publication of results). This position will contribute to regulatory documents, including summaries of unmet medical need and disease burden as well as requests for regulatory feedback on effectiveness studies.

This is the first position within this asset, and reflects the increased importance of pipeline assets to address respiratory disease. We anticipate as products come nearer to launch that the incumbent will take the lead to expand this team with additional FTEs; consequently, the incumbent must be someone who wants to start a team sees themselves as a leader. 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. The position will also be supported by a Regulatory Team. Additionally, accountability for the clinical development program lies outside of MDSCA within Pfizer research groups.

This is a high-level position that requires skill and experience with clinical drug development studies, epidemiology, managing the scientific aspects of complicated long-term projects, interacting with world experts on RSV disease and antivirals, growing and managing a team, operating in varied cultural settings, and integrating within a multi-disciplinary team at Pfizer.

ROLE RESPONSIBILITIES

Under the initial supervision of the Scientific Affairs Lead, RSV Antiviral/ Adult Vaccine Program, take the primary lead for scientific/medical affairs activities for the developing medical plans for Respiratory Vaccines and Antivirals Pipeline Assets, with an initial focus on RSV antiviral:

• Represent MDSCA at the global program/medicine team
• Provide expert medical/epidemiologic input into clinical development program and study design
• Advise in appropriate/high quality data for use in cost-effectiveness modelling
• Design and execute epidemiology studies to support pipeline assets
• Assemble/track/generate epidemiologic data to support clinical trial conduct and design
• Lead field epidemiology studies involving primary data collection
• Identify, establish, and maintain relationships with external partners that can collaborate with high priority global studies
• Oversee all aspects of study design (e.g., methodology, protocols, analytic plans) for high priority epidemiologic and other scientific studies.
• 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 testing policies and algorithms may affect study design.
• 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 as well as real-world data analyses.
• Grow the pipeline assets team
• Identify when additional resources are needed
• Work with project management and the overall Respiratory Vaccines and Antivirals lead to establish and expand a budget
• Hire additional FTEs
• Transition to a management role as required
• Lead publications team for pipeline assets epidemiologic and observational studies/evaluations
• Work with internal and external experts to develop abstracts and present data for scientific congresses, including taking the lead for writing and presenting
• Oversee or 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)
• Plan/conduct Advisory Boards and Brand Expert Panels seeking guidance on product positioning and related issues.
• Provide epidemiologic support to cost-effectiveness modelling by advising on high-quality inputs for models.
• Participate in the Epidemiology Sub-committee (ESC) and Medical Scientific Committee, both of which review all study proposals
• Participate in the Respiratory Vaccine Leadership Team meeting

BASIC QUALIFICATIONS

• MD required with expertise in vaccinology, vaccine clinical development, and epidemiology.
• At least 5years 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
• Experience in or strong interest in management.
• 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 respiratory vaccines, pathogen epidemiology, or antivirals considered a major plus but not required
• Documented ability to manage projects to completion.
• Documented ability to take a relevant infectious 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 respiratory pathogen epidemiology
• Able to review, evaluate, interpret, and present complex data; understand the emerging safety and efficacy profile of respiratory vaccine and antiviral pipeline assets
• Understand the critical data elements related to assessing the public health value of respiratory vaccines and antivirals, ability to oversee or conduct public health analyses of intervention impact, and ability to interpret data and data limitations for both Pfizer and competitor respiratory vaccine and antiviral products.
• 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

PREFERRED QUALIFICATIONS

• Experience working on phase 1, 2, 3 studies in a clinical development program
• Direct experience overseeing post-authorization efficacy or effectiveness studies
• 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)

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Travel approximately 20%

The annual base salary for this position ranges from $253,800.00 to $423,000.00. 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.

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.

Medical

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