Director, GHEOR Patient-Reported Outcomes Assessment (PROA), Immunology/Cardiovascular

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Summary:

Define and oversee the execution of clinical outcomes assessment (COA) strategies for the rigorous development and implementation of patient/clinician reported measures across immunology and cardiovascular 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

• 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 cardiovascular 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 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 securing and maintaining patient access 

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Compensation Overview:

Field - United States - US: $211,880 - $256,748

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stoc