Senior Director, RWE/Epi Scientist Internal Medicine - Migraine

Pfizer•New York, MA

1d•Remote

About The Position

Role Summary The Senior Director Internal Medicine (SD), individual contributor, will generate real-world evidence (RWE) and epidemiology (Epi) studies in support of US 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: Design, lead and execute RWE/Epi studies as part of cross-functional IEPs Provide subject matter expertise (SME) and thought leadership to advance Pfizer’s use of RWE/Epi to develop high value medicines. Partner with TA RWE/Epi lead and MEG TA Leads to ensure strategic input is being provided to IEPs through Global Medical Affairs Teams Work collaboratively to establish & operationalize processes & systems to deliver RWE/Epi studies and other deliverables to execute on IEP plans Stakeholder management: build coalitions & develop strong partnerships across disciplines & geographies to optimize RWE/Epi team’s performance / contribution Provide critical assessments to inform asset-specific development strategy & cross-functional decision-making and review of epidemiological data and literature, when needed. Prepare study reports, and present /publish results of epidemiological studies at scientific conferences and in peer-reviewed journals Participate in RWE/Epi peer review of study protocols and study reports Provide SME on US RWD available at Pfizer, including major differences between databases and which types of research questions each can answer 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 Ability to rapidly assess feasibility of answering research questions with available RWD Manage feasibility analyses for development of study concepts Develop study concepts, present to GMAT and other appropriate governance, and address concerns until concepts are approved Develop study protocols for approved concepts, present to GMAT, address concerns, and ensure they are conducted according to governing SOPs Supervise and mentor more junior team members Act as SME for observational and NIS study design in accordance with generally accepted scientific principles and regulatory guidance

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).
This position requires permanent work authorization in the United States.

Nice To Haves

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
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.

Responsibilities

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

Benefits

eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 25.0% of the base salary and eligibility to participate in our share based long term incentive program
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.

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