Job Title: PRO Specialist Position Description To maximize the value of multiple agents within a therapeutic area by developing Patient Reported Outcome (PRO) strategies during early clinical development. 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. Position Responsibilities Lead PRO activities for a therapeutic area and develop 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 develop PRO strategies Ensure relevant PRO endpoints and study design for registration clinical trial programs meet the needs of global regulatory agencies and key stakeholders Identify PRO instruments and evaluate measurement and psychometric properties of the instruments Work with external key opinion leaders and regulatory agencies to obtain guidance on PRO strategies 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 Develop and/or validate 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 develop 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 Position Requirements Advanced degree in psychology, epidemiology, health services research, outcomes research or related discipline preferred with at least five (5) years professional experience in PRO assessment and/or psychometric validation. 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 and regulatory agencies to inform the development of patient reported outcome strategy preferred. Professional experience across multiple therapeutic areas, 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. Benefits Blue Cross/Blue Shield Medical and Vision Dental Insurance 401K Plan with Company Match Holiday and Vacation Pay Relocation Assistance
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