Director, RWE/Epi Scientist RSV OA/COVID/FLU & Pipeline

Role Summary

This position will assume a high-impact and global role within the Vaccines Real-World Evidence (RWE) and Epidemiology group, with a focus on adult respiratory viral vaccines (e.g. COVID, RSV). The director will lead RWE and epidemiologic studies generating evidence on disease burden, vaccine effectiveness, and vaccine impact. Evidence generated from these studies will be used to inform vaccine recommendations, utilization of licensed vaccines and the development and licensure of future vaccines, as well as for scientific publication and congresses. This is a high-level position that requires skill and experience in field epidemiology, infectious disease surveillance, and real-world database studies. The role will involve managing the scientific aspects of complicated long-term projects, interacting with external experts on respiratory vaccines, and integrating within a multi-disciplinary team at Pfizer. This position is part of a newly formed Vaccines RWE/epidemiology team and will work cross-functionally with collaborators spanning Medical teams, Research Units, and the Chief Medical Officer organization (Medical Evidence Development, Regulatory, Safety, Data Sciences & Analytics, etc.) to design, execute, and disseminate results from studies. The role requires deep expertise in RSV and/or COVID-19 disease and epidemiologic methods. Additional areas of focus may also include Influenza and pipeline vaccines.

Responsibilities

• Lead observational and interventional epidemiological studies evaluating vaccine preventable disease burden, effectiveness, and impact, including studies conducted as post-approval commitments for regulatory agencies. These include studies using large real-world databases (e.g. claims data, electronic health records), as well as field epidemiology studies with prospective enrolment.
• Work collaboratively to ensure high quality methods and designs in the pre and post licensure settings (e.g. assessing burden estimates for the former, and post-authorization effectiveness or impact studies for the latter)
• Co-develop RWE protocols in collaboration with the cross-functional asset teams, including but not limited to the medical evidence strategist, biostatistics and clinical affairs.
• Coordinate cross-functional teams to create high quality RWE from rigorously designed protocols
• Analyze/interpret and present data for use with internal/external experts.
• Provide guidance on the most appropriate types of data, datasets, and methodology for a given problem, and coordinates RWE project execution with appropriate internal and partner analytic resources and tools.
• Act as the RWE subject matter expert for the Vaccines franchise and lead projects independently.
• Integrate RWE into their strategic plans and use these plans to identify key RWE teams‚Äô external data partnership opportunities.
• Oversee data procurement activities (e.g., landscape assessments and due diligence or supporting contract development for external studies).
• With the assistance of RWE programming teams, advise on conducting feasibility assessments to determine appropriate internal / external real-world data sources
• Document all requests and track progress toward project completion, other metrics, and business goals.

Qualifications

• Advanced degree in Epidemiology or a related field, with a minimum of 4 years of relevant experience for MDs, 5+ years for PhDs/PharmDs, and 7+ years with a Master's/MPH, in the pharmaceutical, academic, medical, or public health environments
• Subject matter expertise in vaccine/vaccine preventable diseases, specifically viral respiratory diseases (RSV, COVID, flu), with 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.
• Strong epidemiological and statistical methods skills used in observational and non-interventional studies.
• Ability to communicate effectively with cross-functional teams and work in a highly matrixed environment, with demonstrated excellence in teamwork and collaboration and strong interpersonal skills
• Documented ability to manage projects to completion
• Documented ability to lead complex projects
• Proven hands-on experience leading and executing non-interventional (NI) studies from protocol design, delivery of results and clinical study report.
• Experience in the following:
  • RSV adult and/or COVID-19 epidemiology
  • Clinical registry, patient generated health data, unstructured clinical data and other health data sources.
  • Understanding global regulatory guidance for appropriate use and submission of RWE.
• Willingness to travel (10-15%) for face-to-face meetings, congresses
• Fluency 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. Relocation support available

Skills

• Knowledge of vaccines development, infectious disease, host/pathogen interactions, immunology
• Understanding global regulatory guidance for appropriate use and submission of RWE.
• Knowledge of global HTAs‚Äô / payers‚Äô RWE acceptance, and experience in value-based agreements, value-based care and similar constructs.
• Data Visualization: passion for and experience in generating easy-to-use, interactive data visualization capabilities (e.g., Tableau, PowerBI, Qlik, Spotfire, Looker).
• Experience integrating real world evidence in early clinical development.
• Experience using RWE to drive value-based care, generally, and value-based contracting, specifically.

Education

• Not specified