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Job Description

The Director of Real World Evidence is responsible for establishing rigorous assessment of real world data to assess the natural history of diseases and real world outcomes for the Vertex early development and clinical portfolio. The Director of RWE will also support the cross-functional global observation research by providing methodologic and analytic support for Global Medical Affairs, Health Economics and Outcomes Research and Global Patient Safety. Along with evidence developed by the RWE COE, these analyses inform the real world utilization and outcomes of Vertex therapeutics inform clinicians, payers, policy makers, patient groups and internal decision making. Additionally, the Director of RWE will shape and influence all aspects of observational research policies. Using an integrated model, he/she will work closely with the Global Patient Safety, Global Medical Affairs, Health Economics and Outcomes Research, Biostatistics, Operations Management, clinical development, regulatory affairs, and across R&D. This is a hybrid position, requiring 3 days per week in the office and 2 days per week remote.

Key Responsibilities

• Study concept development and execution of natural history of disease assessment for business and development and early development indications
• Strategic and tactical support for cross-functional RWE development including registries, natural history of disease for regulators, payers and clinicians
• Strategic and tactical support for developing RWE historical control and methods
• Establishing innovative methods and integrating into HEOR, global safety and medical affairs observational research
• Rotating member of non-interventional study protocol review groups
• Adapt performance metrics and dashboards for RWE project within their therapeutic area
• Assess real world data assets and establish real world data plan, including data licenses and data platforms
• Global observation research functional expert on cross functional brand strategy teams for assigned brand/pipeline, newly launched and marketed Vertex product(s)
• Assess research gaps and objectives across key partners and disease areas to determine proactive observational research strategy
• Possess superb communication skills, advanced customer experience, comprehensive understanding of Vertex strategies to translate observational research methods and results to diverse audiences
• Effectively manage internal and external stakeholder expectations regarding strategic objectives and execution of research

Minimum Qualifications:

• PhD in biostatistics, epidemiology, health economics and outcomes research, health policy, or similar required
• Formal training in Epidemiology/Health Services Research required
• At least 5 - 7 years-experience in observational research study management AND data analytics, either within industry or with an observational research consulting firm

• Solid understanding of the 21st Century Cures Act and the opportunities for use of RWE to inform regulatory decision makers
• Advanced knowledge in observational research design
• Excellent interpersonal communication and study management skills
• Ability to take detailed observational study results and communicate them in a clear, non-technical manner to internal cross-functional teams, using language that resonates with the teams, while maintaining the integrity of key findings
• Ability to work effectively in a constantly changing, diverse, and matrix environment

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