Real World Evidence Associate Director

Vertex Inc.•Boston, MA

1d•$174,400 - $261,600•Hybrid

About The Position

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 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.

Requirements

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
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

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