Real World Evidence Sr Manager
Reporting to the Director, RWE Center of Excellence (COE), the Senior Manager, RWE, is integral member of the RWE COE team who leverages expertise in epidemiology, real world data, and other relevant disciplines to assess the incidence, prevalence, natural history, burden of illness, and real world outcomes for Vertex pipeline and portfolio products. The Senior Manager, RWE, will support cross-functional global observation research by providing methodological and analytical support for internal stakeholders, including Global Medical Affairs, Health Economics and Outcomes Research, Global Patient Safety, and Government Affairs and Public Policy. The Senior Manager, RWE, will also develop and execute on tactics related to the collection and/or analysis of real world data to provide insights to inform external stakeholders, including clinicians, payers, policy makers, and patient groups.
General Responsibilities and Required Skills:
The Senior Manager, RWE, is an individual contributor role, working closely with the Director, RWE, to develop observational research, to inform internal and external stakeholders on the incidence, prevalence, burden of illness (BOI), natural history (NH) of disease, and real world outcomes within a therapeutic area. The Senior Manager, RWE, works cross-functionally to support the execution of observational research across the portfolio.
With guidance and direction from the Director RWE, the Senior Manager, RWE, will:
- Lead focused/targeted research of epidemiology of specific disease areas, including incidence/prevalence, BOI, and NH of disease for business development and early development indications
- Lead registry strategy for early development and early clinical indications to support BOI or NH of disease needed for regulators, payers, and clinicians
- Lead and execute evaluation of available registries and other data sources related to BOI or NH
- Determine potential use of RWE historical control within clinical development program and feasibility of obtaining data required for historical control
- Assist in the development of novel AOP tactics proposed for programs currently in clinical development based on cross-functional program needs
- Lead execution of approved AOP tactics within assigned indications
- Support or lead Study Execution Teams for observational studies
- Develop draft protocol concept and related materials for review and approval by NIPPRC and Statistical Review Forum
- 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, BOI, or NH are discussed
- Represent RWE on cross-functional collaborations and working groups for pipeline product(s)
- Utilize strong communications skills and understanding of Vertex strategies to promote and translate RWD/RWE methods and activities across the company
- Give presentations on RWE methods and studies to internal and external audiences
- 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
- PhD in biostatistics, epidemiology, health economics and outcomes research, health policy, or similar required
- Formal training in Epidemiology/Health Services Research required
- Minimum 3 years of experience working in observational research within the life sciences industry or relevant academic, government, or consulting environment
- Minimum 1 year of experience working in RWE at a biopharmaceutical company
- Understanding of the 21st Century Cures Act and the opportunities for use of RWE to inform regulatory decision makers
- Demonstrated ability to design and execute observational research
- Strong 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
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 ***************@vrtx.com.
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