Senior Director, RWE/Epi Scientist Internal Medicine Full-time

Senior Director Internal Medicine

The Senior Director Internal Medicine (SD), individual contributor, will generate real-world evidence (RWE) and epidemiology studies in support of U.S. migraine strategies across the entire drug development process. The SD must be a subject matter expert in RWE and epidemiology. The SD must ensure that RWE/Epi studies are aligned with Medical Evidence Generation (MEG) Asset Leads and are endorsed in the Integrated Evidence Plan (IEP). The SD will author and review study protocols, reports, and presentations, and will be responsible for communications in writing and in presentations to internal stakeholders, regulatory authorities, medical professionals and others. The SD will be accountable for the quality, timeliness, and efficiency of their RWE/Epi deliverables. The SD will be a strategic partner to the RWE/Epi therapeutic area (TA) lead and will contribute to innovation and process improvement.

In this role, you will:

1. Design, lead and execute RWE/Epi studies as part of cross-functional IEPs
2. Provide subject matter expertise (SME) and thought leadership to advance Pfizer's use of RWE/Epi to develop high value medicines.
3. Partner with TA RWE/Epi lead and MEG TA Leads to ensure strategic input is being provided to IEPs through Global Medical Affairs Teams
4. Work collaboratively to establish & operationalize processes & systems to deliver RWE/Epi studies and other deliverables to execute on IEP plans
5. Stakeholder management: build coalitions & develop strong partnerships across disciplines & geographies to optimize RWE/Epi team's performance / contribution
6. Provide critical assessments to inform asset-specific development strategy & cross-functional decision-making and review of epidemiological data and literature, when needed.
7. Prepare study reports, and present /publish results of epidemiological studies at scientific conferences and in peer-reviewed journals
8. Participate in RWE/Epi peer review of study protocols and study reports
9. Provide SME on US RWD available at Pfizer, including major differences between databases and which types of research questions each can answer
10. Deep expertise in common types of commercially available RWD in the US, including closed claims, open claims, structured EHR, unstructured EHR, linked claims + EHR, hospital chargemaster, surveys, telehealth, and registries
11. Ability to rapidly assess feasibility of answering research questions with available RWD
12. Manage feasibility analyses for development of study concepts
13. Develop study concepts, present to GMAT and other appropriate governance, and address concerns until concepts are approved
14. Develop study protocols for approved concepts, present to GMAT, address concerns, and ensure they are conducted according to governing SOPs
15. Supervise and mentor more junior team members
16. Act as SME for observational and NIS study design in accordance with generally accepted scientific principles and regulatory guidance

Here Is What You Need (Minimum Requirements)

• Advanced degree, including PhD in Epidemiology, population health, outcomes research, or a related discipline and 7+ years of relevant experience in the pharmaceutical, academic and/or medical environments (at least 3 of which need to be at a pharmaceutical company or partnering with pharmaceutical companies); or MPH or another relevant Masters degree, and 10+ years of experience with similar requirements as previously stated.
• Experience operating within large cross-functional matrices and collaborating with multiple partners.
• Strong technical expertise, analytic ability, creative problem-solving, and communication skills.
• Experience directing analyses of real-world data.
• Proven hands-on experience executing non-interventional studies (NIS) from protocol design to delivery of results and clinical study report.
• Knowledgeable of the external regulatory environment for RWE and maintains awareness of scientific developments in epidemiology, medicine, and technology (e.g., artificial intelligence).

Bonus Points If You Have (Preferred Requirements)

• Ability to develop and implement strategic plans and business objectives.
• Strong problem-solving skills and the ability to influence senior leadership.
• Prior experience in developing RWE for neurological conditions (e.g., pain, headache, migraine) where key patient-reported outcomes that may not be readily available in RWD.

Work Location Assignment: Hybrid / Not Remote

Relocation Support Possible