Director, GHEOR Patient-Reported Outcomes Assessment (PROA), Cell Therapy

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Summary:

Define and oversee the execution of clinical outcomes assessment (COA) strategies and implementations for the rigorous development and implementation of patient/clinician reported measures across Cell Therapy portfolio.

Responsibilities:

• Responsible for implementation of optimal COA strategy including managing research to support the selection, development and validation of COA measures.

• Maximize the impact of evidence of treatment benefit by providing input to briefing packages, publication strategies, and market access strategy

• Support eCOA design and implementation such as providing input to eCOA supplier contracting, kick-off and design meetings, and input in the development of company eCOA standards.

• Coordinate with functional counterparts in the development and review of eCOA documentation, including data model specifications, project plans, user acceptance testing scripts, device screenshots, site user guides and training slides, and data migration plans.

• Be an ambassador for PROA and promote the importance of PROA’s role to quantitative and qualitative COA across senior BMS leadership

• Demonstrate leadership for COA strategy with a strong influence across BMS leadership matrix

• Prepare relevant sections of documents and communications for regulatory agency meetings, support and/or participate in said meetings at regulatory agencies, and provide robust evidence in support of submission activities.

• Support dissemination of COA results from clinical trials as well as COA development and validation studies that are aligned with publication strategy

• Participate in global external collaborations regarding policies, standards, and use of COA measures (e.g., PRO Consortium, BIO PFDD Task Force, EuroQol Group, ISPOR working groups)

• Participate in creating and delivering education on COA measures for internal business partners

• Assist operations staff in securing licenses and commissioning translations/adaptations for COA instruments in a timely manner

Qualifications:

• Preference will be given to candidates with a Ph.D. or equivalent degree in a relevant discipline (e.g., psychology, psychometrics, outcomes research, public health) or those who possess a clinical doctorate (M.D., Pharm.D.) coupled with a master’s degree.

• Minimum of 7 years of related experience, including a minimum of 5 years of pharmaceutical industry or CRO experience

• Experience with the application of COA measures in immunology and neuroscience areas preferred

• Experience conducting observational research involving PRO data collection and the interpretation and communication of results to key stakeholders

• Experienced with COA requirements for regulatory and HTA/reimbursement agencies, including understanding of the FDA Patient-Reported Outcomes Guidance

• Strong record of publication in COA

• Knowledge of development and validation of COA measures

• Understanding of health care markets and regulatory and reimbursement decision making, especially in relation to the global use of COA data

• Be abreast of rapidly changing methodological and regulatory environment with regard to COA

• Knowledge of the drug development process within immunology/neuroscience strongly preferred

• Strong analytical and synthesis skills with regard to qualitative and quantitative data

• Demonstrated ability to understand and communicate with matrix teams to achieve the BMS’ vision of shaping the portfolio and secu