Real World Evidence Associate Director

Job Description

General Summary:

The 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 the 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.

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 the potential use of RWE historical control within the clinical development program and the feasibility of obtaining the 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 the 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)
• Utilise strong oral communication 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 the company's publications strategy via the development of conference abstracts, presentations, and 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:

• Proven experience in a similar role is required, preferably following a PhD or an equivalent combination of education and work experience.

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.

#LI-Hybrid

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