Reporting to the Vice President and Head of the Real World Evidence Center of Excellence, the Executive Director of Real World Evidence is responsible for RWE leadership across key internal cross-functional leadership teams and represents Vertex at external US and Global working groups focused on evolving RWE methods and applications. The Executive Director of RWE will shape and influence all aspects of global observational research, particularly the execution of observational research to inform development and regulatory strategies. These analyses inform the real world utilization and outcomes of Vertex therapeutics inform clinicians, payers, policy makers, patient groups and internal decision making.
Leveraging advanced communication and translation skills, strategic planning, and consensus building across Regulatory, Biostatistics, Global Medical Affairs, Global Clinical Development, Early Clinical Development, Translational Medicine, Health Economics and Outcomes Research, International Medical Affairs, Market Access, Patient Advocacy and Digital Sciences. The Executive Director oversees the strategic planning and execution of real world evidence conducted by RWE directors and their direct reports, across the portfolio, to ensure the timely delivery of scientifically valid epidemiology and observation research in rare diseases.
- First line manager for RWE disease area directors across the portfolio
- Assess research gaps and objectives across key partners and disease areas to determine epidemiology/observational research strategy, research objectives and tactical plans for cross disease area projects, as well as appropriate differentiation strategies
- Possess superb communication skills, advanced multi-stakeholder experience, comprehensive understanding of Vertex business and development goals, and a highly-evolved capability to translate RWE methodology to diverse audiences
- Effectively manage internal and external stakeholder expectations regarding strategic objectives and execution of research
- Responsible for robust study concept development and execution of incidence/prevalence, burden of Illness and natural history of disease assessment for key disease areas/initiatives
- Cross-functional collaboration with Global Clinical Development to provide strategic and tactical leadership for developing RWD historical control and methods
- Establishing innovative methods and integrating into RWE, global safety and medical affairs observational research
- Identify opportunities for efficient development of innovative research initiatives and application across disease areas
- Ability to make compliant decisions and execute on those decisions in their research agenda within RWE standard operating processes and working documents
- Oversee RWE study leads compliance with study conduct and tracking according to standard operating processes and working documents
- Proactively identify opportunities and initiate process improvements for optimal quality, cost, speed, innovation, efficiency and effectiveness
- Support VP & Head of RWE COE in developing and implementing operational processes for internal department as it relates to daily RWE activities
- Participate in multiple projects to ensure RWE capabilities are utilized, both cross-functionally and internally
- Serve as delegate for VP & Head of RWE COE on key teams including NiPPRC
- Oversee performance metrics and dashboards for RWE projects across the portfolio
- Assess real world data assets and establish real world data plan, including data licenses and data platforms, in collaboration with RWD Governance Committee
Key Internal Stakeholders:
Regulatory, Biostatistics, Global Medical Affairs, Global Clinical Development, Early Clinical Development, Translational Medicine, Health Economics and Outcomes Research, International Medical Affairs, Market Access, Patient Advocacy and Digital Sciences.
- PhD in biostatistics, epidemiology, health economics and outcomes research, health policy, or similar required
- Formal training in Epidemiology/Health Services Research required
- At least 12+ years-experience in observational research study management AND data analytics, either within industry or with an observational research consulting firm
- Demonstrated leadership in global role leading strategy across multiple disease areas
- Demonstrated development of talented observational researchers within a matrix environment
- Solid understanding of global conduct of observational research, including privacy standards
- 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
- Strong working knowledge of the Microsoft Office Suite (Word, PowerPoint, Excel)
Associated topics: corporate development, evp, executive director, front office, general management, manager iii, manager iv, overall, regional vice president, state president
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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