Real World Evidence Senior Manager (Hybrid)

Job Description

Knowledge and Skills:

Education and Experience:

• The Real World Evidence Senior Manager is an integral member of the RWE team who leverages expertise in epidemiology, real world data, and other relevant disciplines to assess the natural history and real world outcomes for Vertex's pipeline and portfolio products. The position will support cross-functional global observational research by providing methodological and analytical support for internal stakeholders, including Clinical Development, Global Medical Affairs, Global Patient Safety, and Government Affairs and Public Policy. The Senior Manager will also develop and execute on tactics related to the collection and/or analysis of real world data to inform relevant stakeholders such as regulatory affairs and clinical development.
• Job Description

  Job Description

  General Summary:

  The Real World Evidence Senior Manager is an integral member of the RWE team who leverages expertise in epidemiology, real world data, and other relevant disciplines to assess the natural history and real world outcomes for Vertex's pipeline and portfolio products. The position will support cross-functional global observational research by providing methodological and analytical support for internal stakeholders, including Clinical Development, Global Medical Affairs, Global Patient Safety, and Government Affairs and Public Policy. The Senior Manager will also develop and execute on tactics related to the collection and/or analysis of real world data to inform relevant stakeholders such as regulatory affairs and clinical development.

  Key Duties and Responsibilities:

• Lead focused/targeted epidemiologic research in support of Vertex's pipeline and established portfolios, including Natural History (NH) of disease and systematic literature reviews
• Ensure scientific rigor and serve as a methodology expert for real world data analyses
• Conduct feasibility assessment of relevant data sources for disease areas and research questions
• Provide expert insights and experience to design and defend fit-for-purpose epidemiologic observational research; Select and implement appropriate analytic methods aligned to research needs
• Determine potential utility and feasibility of RWE historical control and/or external controls in support of clinical development programs
• Collaborate with and manage vendors, to ensure meeting project timelines and goals
• Support Study Execution Teams for observational studies
• Develop draft study protocol and statistical analyses for review and approval from internal scientific review committees
• Contribute to development of performance metrics and dashboards for RWE projects
• Represent RWE on cross-functional collaborations and working groups for pipeline product(s)
• Able to balance multiple projects in a fast-paced environment
• Utilize strong oral and visual communication skills and understanding of Vertex strategies to promote and translate value of RWD/RWE methods and studies across the company
• Excellent communication skills (oral and written) with internal and external audiences
• Contribute to company publications strategy via development of conference abstracts, presentations, peer- reviewed manuscripts based on the findings of RWE studies
• Working 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 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 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 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 and/or Epidemiology at a biopharmaceutical company

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Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

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