Associate Director

Job Description General Summary

The RWE Associate Director is an integral member of the RWE team who leverages expertise in epidemiology and real world data to develop fit-for-purpose observational research, and to inform internal and external stakeholders on natural history (NH) of disease and real world outcomes within their assigned therapeutic area. The RWE Associate Director works cross-functionally to support the execution of observational research across the portfolio.

• Independently lead focused/targeted research of epidemiology of specific disease areas, including NH of disease for business development and early development indications
• Lead data sourcing strategy for early development and early clinical indications to support NH of disease needed for regulators, payers, and clinicians
• Lead and execute evaluation of available registries and other data sources related to NH and evidence to support clinical endpoints and inclusion/exclusion criteria
• Determine potential use of RWE historical control within clinical development program and feasibility of obtaining data required for historical control
• Lead execution of approved research tactics within assigned indications
• Develop draft protocol concept and related materials for review and approval by internal scientific review boards
• Working closely with stakeholders, align RWE research study tactics with functional and disease program goals
• Contribute to development of performance metrics and dashboards for RWE projects
• Represent RWE on relevant GMDA Sub-Teams, Program Teams, or Disease Strategy Teams where studies related to RWE are discussed
• Represent RWE on cross-functional collaborations and working groups for pipeline product(s)
• Utilize strong oral communications skills and understanding of Vertex strategies to promote and translate RWD/RWE methods and activities across the company
• Support and facilitate external research collaborations with key academic partners, consortia, and data vendors
• Support the development of cross-functional evidence generation planning
• Provide leadership and mentorship within RWE
• Contribute to company publications strategy via development of conference abstracts, presentations, peer-reviewed manuscripts based on the findings of RWE studies

• Applied knowledge of relevant RWE regulatory agency guidance and position papers and the opportunities to use RWE to inform regulatory decision making
• Demonstrated ability to design and execute observational research
• Strong and clear interpersonal communication, presentation, 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 collaboratively in a constantly changing, diverse, and matrix environment

• PhD (preferred), or MS/MPH in epidemiology, biostatistics, health economics and outcomes research, or similar required
• Formal graduate training in Epidemiology/Health Services Research required
• Minimum 5 years of experience working in observational research within the life sciences industry or relevant academic, government, or consulting environment
• Minimum 3 years of experience working in RWE and/or Epidemiology at a biopharmaceutical company

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and…