Job Description
General Summary:
The Real World Evidence (RWE) Associate Director is an integral member of the RWE team, who leverages expertise in epidemiology and real-world data to develop fit-for-purpose observational research and to inform internal and external stakeholders on natural history (NH) of disease and real-world outcomes within their assigned therapeutic area. The RWE Associate Director works cross-functionally to support the execution of observational research across the portfolio. This position is Boston-based with a hybrid schedule, allowing for 2 days per week remote work and 3 days per week in the Fan Pier office. (Relocation assistance is available).
Key Duties and Responsibilities:
- Independently lead focused/targeted research of epidemiology of specific disease areas, including NH of disease for business development and early development indications.
- Lead data sourcing 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 and evidence to support clinical endpoints and inclusion/exclusion criteria.
- Determine potential use of RWE historical control within clinical development program and feasibility of obtaining data required for historical control.
- Lead execution of approved research tactics within assigned indications.
- Develop draft protocol concept and related materials for review and approval by internal scientific review boards.
- Working closely with stakeholders, align RWE research study tactics with functional and disease program goals.
- 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 are discussed.
- Represent RWE on cross-functional collaborations and working groups for pipeline product(s).
- Utilize strong oral communications skills and understanding of Vertex strategies to promote and translate RWD/RWE methods and activities across the company.
- Support and facilitate external research collaborations with key academic partners, consortia, and data vendors.
- Support the development of cross-functional evidence generation planning.
- 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:
- Applied 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 and clear interpersonal communication, presentation, 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.
Education and Experience:
- 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 5 years of experience working in observational research within the life sciences industry or relevant academic, government, or consulting environment.
- Minimum 3 years of experience working in RWE and/or Epidemiology 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.
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