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Job Description
The Director, Real World Evidence assists in developing and implementing strategy for observation research, to inform internal and external stakeholders on the incidence, prevalence, burden of illness, natural history of disease and real world outcomes of treatment within a therapeutic area. The Director works cross-functionally to content expertise and tactical support for the execution of observational research across the portfolio. He/she functions as a point person for observational research methodologies, including execution of observational research in rare diseases.
Key Responsibilities
- Study concept development and execution of incidence/prevalence, burden of Illness and natural history of disease assessment for business and development and early development indications
- Strategic and tactical support for cross-functional RWE development including registries, burden of Illness/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
Preferred Qualifications:
- 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
- Strong working knowledge of the Microsoft Office Suite (Word, PowerPoint, Excel
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Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Human Resources at ApplicationAssistance@vrtx.com.