Senior Manager, Epidemiology Scientist

Role Summary

Pfizer's Global Medical Epidemiology (GME) group conducts observational epidemiologic research, often using large healthcare databases, to generate a better understanding of disease context and medical outcomes to improve medical decision-making for Pfizer medicines development. The three pillars of GME's remit are: (i) Regulatory Use of Epidemiology Data, (ii) Disease Natural History Studies to inform Clinical Trial Design, and (iii) Epidemiology Data for Quantitative Benefit-Risk Assessment. GME's impacts include improving the efficiency and likelihood of success of early phase clinical trials, building more robust benefit-risk profiles to provide a more thorough assessment of new products, and generating pivotal epidemiologic evidence to support regulatory filings. GME's value is based on deeper understanding of disease that improves quality and precision of Pfizer medical decisions. Our mission is to employ scientific methods and principles of epidemiology to secure regulatory approval, accelerate clinical development, and build benefit-risk profiles

We are looking for a collaborative and innovative team member to join GME and contribute to our mission of understanding diseases across all stages of drug development, which accelerates the availability of breakthrough medicines that impact patients' lives.

The Senior Manager, Epidemiology Scientist position provides an opportunity for a trained epidemiologist to play an essential role in advancing the generation of real-world evidence and its application to drug development. This role requires someone with strong epidemiology training, analytic ability, problem solving, and communication skills.

The Senior Manager, Epidemiology Scientist will also partner with internal and external stakeholders on the design and conduct of epidemiologic research to inform clinical development programs and to support regulatory submissions to the FDA, EMA and other agencies globally. Under the direction of the Oncology Strategic Lead, the role will involve internal and external collaborations inconceptualizing and proposing epidemiologic studies, and in writing and reviewing protocols, reports, and presentations. Studies will be communicated in writing and in presentations to internal stakeholders, regulatory authorities, medical professionals and others.

Under the oversight of the Oncology Strategic Lead, the incumbent will also develop and adopt innovative pharmacoepidemiologic methodologies and contribute thought leadership internally and externally regarding Pfizer's understanding of disease epidemiology/ pharmacoepidemiology to support decision-making across portfolios.Specifically, the incumbent will support multiple GME Oncology activities, including background epidemiology studies, regulatory requests, and external cohort studies, in addition to other therapeutic area epidemiology activities.

This position will report directly to the Epidemiology Oncology Strategic Lead, Global Medical Epidemiology. GME colleagues are located in Collegeville, PA and New York but Pfizer is flexible regarding remote work for the right candidate.

Role Responsibilities

Major Responsibilities

Propose and produce GME deliverables for development and product/asset teams, including:

• Background safety and effectiveness epidemiology studies and disease natural history studies.
  
• Indicated population cohorts for external control arms and regulatory submission.
  
• Post-approval effectiveness studies
  
• Feasibility assessments and identification of fit-for-purpose data for observational research
  
• Other epidemiology studies (e.g., special subpopulations, new indications)
  
• Critical assessment and review of epidemiological data and literature
  
• Design and implement primary or secondary data collection or hybrid design pharmacoepidemiologic studies intended to quantify benefits and/or risks potentially associated with Pfizer products
  
• Present and publish results of epidemiological studies at scientific conferences and peer-reviewed journals
  
• Participate in GME peer review of study protocols and reports
  
• Support multiple product teams on epidemiology related issues
  
• Work collaboratively with key stakeholders internally (such as Clinical, Medical, Regulatory, Outcomes Research, and Data Scientists) and externally (such as academics, regulators, vendors)
  

Basic Qualifications

• PhD in e pidemiology or a quantitative public health discipline OR Master of Public Health (MPH), Master of Science (MS) in epidemiology or a related discipline with at least 7 years relevant work experience
  
• 1-3 years in developing epidemiological assessments and researching natural history of disease in the pharmaceutical industry, academia, and/or regulatory agencies
  
• Practical experience with implementation of observational or experimental studies
  
• Ability to discern strengths and limitations of real-world datasets - such as electronic health records, claims, clinical data registries, patient generated health data, and other health data sources - in context of designing epidemiology study designs
  
• Ability to prioritize and operate in a fast business environment, while not compromising on scientific quality and rigor
  
• Change agile and able to manage diverse portfolio of research projects
  
• Demonstrated ability to negotiate scientific and operational decisions with cross-functional teams, external collaborators; supports regulatory interactions
  
• Excellent written and verbal communication skills and the ability to work cross-functionally and collaborate with internal stakeholders and shared services customers
  
• Self-starter with the ability to thrive in a fast-paced, ambiguous environment. M ust be highly motivated and desire to constantly learn new skills, systems and processes as continuous innovation and problem solving is expected
  
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, and oversee/ lead projects to their successful completion
  

Preferred Qualifications

• Experience in oncology disease area (i.e., cancer genomics in precision medicine)
  
• Experience in safety signal refinement and evaluation
  
• Consulting experience in epidemiologic research a plus
  
• Demonstrated record of peer-reviewed publications
  

Physical/Mental Requirements

The position will require the ability to search for, read, and synthesize large volumes of scientific literature.

Other Job Details:

• Last Date to Apply for Job: April 22, 2021
• Additional Location Information: Preference for candidate to be based in New York, NY or Collegeville, PA but also open to US remote for the right candidate
• Eligible for Relocation Package
• Eligible for Employee Referral Bonus

Sunshine Act

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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.

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