Job Overview:

Minimum 8-year experience in epidemiology, pharmacoepidemiology, non-interventional studies (prospective studies, patient registries, retrospective database studies), RWE generation in biopharmaceutical industry or CROs.
•    Reports directly to the FSP Fortrea Line Manager.
•    Receives projects-specific requests and strategic-operational guidance from the Head of Clinical Innovation, Head of Clinical Feasibility.

Summary of Responsibilities:

• Critically appraise existing epidemiology evidence and create new evidence through delivery of specific research questions/protocols and analysis of healthcare databases.
• Conceive and design epidemiological studies aimed at improving disease understanding relevant to Target Product Profile definition and product development: incidence, prevalence, risk factors, natural history course, treatment patterns, co-morbidities, co-medications, outcome measures, phenotypes, biomarkers, unmet needs, and their variations across domains such as demographics and geographies.
• Lead the definition of the RWE part of the Global Clinical Development Plan, both pre-approval and post approval (e.g. PASS).
• Identify RWE approaches to optimize clinical development during study design (e.g. synthetic arms, pragmatic trials, hybrid trials, etc) and execution (e.g. RWE approaches for protocol feasibility assessment, site/physicians identification, etc).
• Contribute to the Evidence Generation Plans to build the project/product value proposition, by designing observational studies, epidemiological studies, retrospective and prospective clinical registries, large electronic medical administrative registries.
• Perform feasibility assessments and identify fit-for-purpose data for RWE research.
• Develop RWE research plans in collaboration with external collaborators in academia or contract research organizations and work effectively with vendors for outsourced studies, based on both primary and secondary data collection, or hybrid approaches, including research question/protocol development and analysis specification following best methodological standards.
• Drive the interpretation of analysis in collaboration with the cross-functional team and communicate analysis interpretation internally and externally.
• Contribute to publication and dissemination of pharmacoepidemiology studies.

As pharmacoepidemiology subject matter expert:

• Collaborate with Scientific Societies on Disease Registries, to maximise the value extraction from their development and interrogation.
• Provide critical appraisal of observational studies and study protocols across the company.
• Support and advise scientifically and from a methodological point of view on Real World Evidence strategies across multiple projects, as subject matter expert.
• Master Pharmacoepidemiology/RWE science and expertise by continuous learning, training, and working.
• Interact and contribute to functional, cross-functional, company-wide or external Pharmacoepidemiology/RWE communities, networks, collaborations, initiatives or goals on knowledge-sharing, methodologies, innovations, technology, regulatory, processes, etc.
• Provides support to the Clinical Innovation Unit interacting with RWE Project management Lead, Clinical Feasibility Head and Clinical Digital Health lead/manager

Learn more about our EEO & Accommodations request here.