Real World Evidence Associate Director (Hybrid)
Boston, MA 
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Job Description

Job Description

General Summary:

The Associate Director, RWE, is primarily an individual contributor role, working closely with the Director/Senior Director/Executive Director/VP, RWE, to develop observational research, to inform internal and external stakeholders on natural history (NH) of disease, and real world outcomes within a therapeutic area. The Associate Director, RWE, works cross-functionally to support the execution of observational research across the portfolio.

Key Duties and Responsibilities:

  • Lead focused/targeted research of epidemiology of specific disease areas, including NH of disease for business development and early development indications
  • Lead registry 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
  • Determine potential use of RWE historical control within clinical development program and feasibility of obtaining data required for historical control
  • Develop 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
  • 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 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

    • Knowledge and Skills:

  • 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

    • Education and Experience:

  • PhD in epidemiology, biostatistics, outcomes research, or similar required
  • Formal 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 year of experience working in RWE at a biopharmaceutical company

    • 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.

     

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    Job Summary
    Company
    Vertex Pharmaceuticals Incorporated
    Start Date
    As soon as possible
    Employment Term and Type
    Regular, Full Time
    Required Education
    Doctorate
    Required Experience
    5+ years
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