Real World Evidence Associate Director - Boston, United States - Vertex Pharmaceuticals, Inc

Vertex Pharmaceuticals, Inc Boston, United States

1 week ago

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 indicationsLead registry strategy for early development and early clinical indications to support NH of disease needed for regulators, payers, and cliniciansLead and execute evaluation of available registries and other data sources related to NHDetermine potential use of RWE historical control within clinical development program and feasibility of obtaining data required for historical controlDevelop novel AOP tactics proposed for programs currently in clinical development based on cross-functional program needsLead execution of approved AOP tactics within assigned indicationsLead Study Execution Teams for observational studiesDevelop draft protocol concept and related materials for review and approval by NIPPRC and Statistical Review ForumContribute to development of performance metrics and dashboards for RWE projectsRepresent RWE on relevant GMDA Sub-Teams, Program Teams, or Disease Strategy Teams where studies related to RWE or NH are discussedRepresent 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 companyGive presentations on RWE methods and studies to internal and external audiencesProvide leadership and mentorship within RWEContribute 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 makersDemonstrated ability to design and execute observational researchStrong interpersonal communication and study management skillsAbility 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 findingsAbility to work effectively in a constantly changing, diverse, and matrix environment

Education and Experience:
PhD in epidemiology, biostatistics, outcomes research, or similar requiredFormal training in Epidemiology/Health Services Research requiredMinimum 5 years of experience working in observational research within the life sciences industry or relevant academic, government, or consulting environmentMinimum 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

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