Job Description:Duties Purpose
To maximize the value of a molecule by supporting the development of Patient-Reported Outcome (PRO) strategies during early clinical development and to implement those strategies. The inclusion of PRO measures in trials is critical for creating robust and differentiated product profiles and for providing information important for therapeutic decision-making to patients, physicians and payers.
Lead PRO implementation activities for a molecule and provide support in developing global PRO strategies for molecules within a therapeutic area.
Work cross-functionally with Global Development, Global Product Strategy, International Business Teams, Global Health Economics and Affiliates to implement PRO strategies Ensure relevant PRO endpoints and study design for registration clinical trial programs meet the needs of global regulatory agencies and key stakeholders Assist in identifying PRO instruments and evaluate measurement and psychometric properties of the instruments Work with external key opinion leaders to obtain guidance on PRO implementation Contribute to the design, implementation, and management of registration clinical trials containing PROs including the development of the PRO sections of study concept documents, study protocols, statistical analysis plans, clinical study reports and other development documents Support the development and/or validation of instruments for PRO as needed Adapt and validate instruments for use in different patient populations, including cultural adaptations and translations Work with Global Scientific Communications to execute a publication plan that is integrated with overall publication strategy to communicate PRO information to physicians, patients, payers, and policy makers Responsible for Vendor management including scope of work development, contract initiation, and project milestones, timelines, deliverables, and budgets
Skills Job Qualifications
Familiarity and experience with the development and implementation of research strategies (including PRO within registration clinical trials).
Strong understanding of research methodology and statistics, as well as demonstrated technical writing and presentation skills.
Experience managing complex projects with external vendors under short timelines.
Demonstrated ability to set clear priorities in managing projects.
Experience working with key opinion leaders to implement studies preferred.
Professional experience in core therapeutic area, with experience in the biotechnology or pharmaceutical industry preferred.
Strong oral and written communication skills, with the ability to communicate effectively to internal and external audiences.
Ability to work effectively in a cross-functional, project team environment.
Advanced degree in psychology, epidemiology, health services research, outcomes research or related discipline preferred with at least three (3) years professional experience in PRO assessment and/or psychometric validation.