Director, Epidemiology Scientist

Key Skills

Data science techniques, Design, Leadership Skill, Management, Operations

Job Description

Pfizer’s Global Medical Epidemiology (GME) group conducts research, often using large, external data bases, to generate a better understanding of disease context and medical outcomes and improve medical decision-making. 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 incorporating these insights to support regulatory filings. GME’s value is based on deeper understanding of disease that improves quality and precision of Pfizer medical decisions. The mission of GME is to employ the 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 Epidemiology Scientist position provides an opportunity for an 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 technical expertise, analytic ability, creativity and communication skills.

The 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. The role will involve internal and external collaborations in conceptualizing 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. 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 position will support safety risk contextualization and regulatory epidemiology activities for all therapeutic areas (with a focus in Oncology and Infectious Disease). GME colleagues are located in New York, Boston, MA and Collegeville, PA.

Role 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
• 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)
• Provide support of and/or attend FDA Advisory Committee meetings and EMA Oral Explanations and other related interactions and negotiations with regulatory agencies on epidemiologic issues as needed

Qualifications

Basic Qualifications

• PhD with at least 3 years’ experience in Epidemiology or another Quantitative Public Health discipline in the pharmaceutical industry, academia, public health or MPH with at least 6 years of the above experience

• Expertise in epidemiology to advise on disease areas, data, technology, and risk management strategies to development projects and marketed products

• 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
• 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

Preferred Qualifications

• 10+ years experience in the pharmaceutical industry following MPH/PhD/MD degree completion, including experience in regulatory interactions regarding clinical or observational research
• Experience in safety signal refinement and evaluation
• Consulting experience in epidemiologic research a plus
• Demonstrated record of peer-reviewed publications
• Preference for incumbent to be based in New York City, NY, Boston (Cambridge), MA, Collegeville, PA or (Seattle area) Bothell, WA

Work Location Assignment: Hybrid; must be onsite min 2.5 days average per week

The annual base salary for this position ranges from $161,600.00 to $269,400.00. 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.

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.