Senior Director, RWE/Epi Scientist Internal Medicine - Migraine

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 is a subject matter expert in RWE and epidemiology, ensuring that RWE/Epi studies are aligned with Medical Evidence Generation (MEG) Asset Leads and endorsed in the Integrated Evidence Plan (IEP). The SD will author and review study protocols, reports, and presentations, and will communicate with internal stakeholders, regulatory authorities, medical professionals and others. The SD is accountable for the quality, timeliness, and efficiency of their RWE/Epi deliverables and will be a strategic partner to the RWE/Epi TA lead, contributing to innovation and process improvement.

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 provided to IEPs through Global Medical Affairs Teams
• Work collaboratively to establish and operationalize processes and systems to deliver RWE/Epi studies and other deliverables to execute on IEP plans
• Stakeholder management: build coalitions and develop strong partnerships across disciplines and geographies to optimize RWE/Epi team’s performance and contribution
• Provide critical assessments to inform asset-specific development strategy and cross-functional decision-making and review of epidemiological data and literature
• 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 research questions each can answer
• Deep expertise in common types of commercially available US RWD, 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 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 scientific principles and regulatory guidance

Qualifications

• Required: Advanced degree (PhD in Epidemiology, population health, outcomes research, or related discipline) and 7+ years of relevant experience (at least 3 in pharma or partnering with pharma); or MPH or relevant Masters with 10+ years of experience
• Required: Experience operating within large cross-functional matrices and collaborating with multiple partners
• Required: Strong technical expertise, analytic ability, creative problem-solving, and communication skills
• Required: Experience directing analyses of real-world data
• Required: Hands-on experience executing non-interventional studies (NIS) from protocol design to delivery of results and clinical study report
• Required: Knowledge of external regulatory environment for RWE and awareness of developments in epidemiology, medicine, and technology (e.g., AI)
• Preferred: Ability to develop and implement strategic plans and business objectives
• Preferred: Strong problem-solving skills and ability to influence senior leadership
• Preferred: Experience developing RWE for neurological conditions (e.g., pain, headache, migraine) with patient-reported outcomes not readily available in RWD; demonstrated leadership and ability to influence and coach others
• Preferred: Work location within 50 miles of a Pfizer site; remote candidates considered; relocation support possible for candidates farther away