Real World Evidence Medical Lead

Job Description

ROLE SUMMARYPfizer has a rich pipeline in innovative products. Robust epidemiology and real world data is required to be generated for these products.The RWE medical Lead will partner with internal and external stakeholders on the design and conduct of epidemiologic research and Real world data generation for new products. The role will involve collaboration with the Medical advisors and Category medical Leads for planning and execution of real world evidence data generation. This role will also with work with RWD/RWE contract research organizations, registries, health systems and academic institutions in advancing RWD, the development/adoption of research methodologies and advocate the generation of effectiveness RWE. He/she will contribute thought leadership internally and externally regarding Pfizer s understanding of disease epidemiology/ pharmacoepidemiology via the leverage of RWE to support benefit-risk justifications across portfolios.This role requires someone with strong strategic thinking, technical expertise, leadership, and communication skills.ROLE RESPONSIBILITIES Carry out below responsibilities, including:

• Epidemiology RWD/RWE Research Strategy for current new and upcoming products
• Background epidemiology studies, natural progression of disease studies and user characterization studies
• Post-approval effectiveness studies and their feasibility assessments
• Other epidemiology studies (e.g., special subpopulations, new indications)
• Provide critical assessment of epidemiological data and literature
• Design and implement multiple database, de novo, or hybrid design studies intended to quantify risks potentially associated with Pfizer products
• Present and publish results of epidemiological studies at scientific conferences and peer-reviewed journals
• Support multiple product teams on epidemiology related issues
  • Work collaboratively with key stakeholders internally (such as Medical, Regulatory, Clinical ) and externally (such as academics, regulators, vendors)

EPI/RWE EXPERTISE

• Superior understanding of and expertise in epidemiology methods, including observational and experimental RWD/RWE study designs and analysis, and appropriate sample size calculation methodology; demonstrated ability to design and implement successful studies
  • Demonstrated ability to conduct high-quality comprehensive literature reviews in the pharmaceutical industry, academia, and/or regulatory agencies
  • Experience writing epidemiological sections of scientific documents such as research summaries, publications, risk management plans, etc.
  • Practical experience with implementation of observational or experimental studies

INTERNAL AND EXTERNAL RESPONSIBILITIESINTERNAL

• Contribute to the continuing education of relevant line functions on the use of RWD/RWE
• Develops and implements strategic communication plans to educate Pfizer stakeholders of the value, opportunities, data, methods, analytics, and processes to implement alternative pathways and studies

EXTERNAL

• Publication and presentation of RWD/RWE projects at internal meetings, and external industry conference/workshops
• Develop effective relationships with external thought leaders in RWD/RWE, comparative effectiveness research, health informatics, and data sciences so as to maintain an extensive understanding of external environment, to create opportunities for engagement, and to establish Pfizer as a leader in the field

QUALIFICATIONS

• PhD or, MD or PharmD with Master s degree, and 5 years of experience in Data Science, Bioinformatics, Clinical Science, Epidemiology, Quantitative Public Health discipline, or related discipline

• Strong preference for 3 or more years experience in the pharmaceutical industry; extensive track record interacting with R&D and commercial organizations in pharmaceutical industry

• Consulting experience in epidemiologic research a plus
• Extensive track record and experience in observational and RWD studies and applying epidemiologic methods to clinical research
• Demonstrated depth of understanding of observational research methods, regulatory standards, comparative effectiveness research, health care and data science trends, and ability to leverage epidemiologic and data science expertise to meet evolving business needs
• Evidence of technical expertise of applying RWD/RWE evidence and insights at the therapy/product level;
• Understanding client challenges and soliciting support for new opportunities to build project portfolio
• Interpersonal skills to seamlessly interact on both business and scientific issues along with negotiation and facilitation skills to align group decisions
• Experienced in managing meetings / projects
• Creative skills in designing alternative approaches, new solutions, or innovations
• Support standardizing and optimizing processes for ease of implementation
• Extensive expertise in RWD/RWE to advise, on disease areas, data, technology, and risk management strategies to development projects and marketed products
• Ability to explain strengths and limitations of RWD/RWE datasets such as electronic health records, claims, clinical data registries, patient generated health data, and other health data sources in context of designing RWD/RWE data study designs

PREFERRED QUALIFICATIONS

• Extensive expertise in RWD/RWE
• Experience in aligning decision-makers in alternative directions prospectively
• Demonstrated ability to develop and maintain strong relationships with external customers and experts
• Excellent matrix, interpersonal and influencing skills
• Financial management experience
• Excellent verbal and written communications skills
• Enlists others to align objectives with those of the organization
• Strong desire to reach challenging goals and continuously improve
• Works tenaciously through difficulties to achieve best results

ORGANIZATIONAL RELATIONSHIPSMedical, Clinical, Regulatory, and SafetyPfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Medical,

Keyskills :
health systemsrisk managementrisk management plansdata sciencemanaging meetingspublic healththought leadershipequal employment opportunityclinical datahealth informaticsstrategic thinking