Patient-Report Outcome Assessment Asset/Indication Lead

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Summary:

As part of the GHEOR Patient-Reported Outcomes Assessment (PROA) team, this role will provide specialized technical expertise in support of the development and execution of Clinical Outcome Assessment (COA) strategy for neuroscience.  The PROA team consists of experts in the measurement of subjective assessments focusing on BMS’ oncology, hematology, neuroscience, cardiovascular, immunoscience and fibrosis franchises. The team plays a key role in developing, assessing, interpreting, and disseminating patient-reported outcomes (PROs), observer-reported outcomes (ObsROs), and clinician-reported outcomes (ClinROs) to assess treatment benefit during the clinical development of new medicines (Phase 2-4). Its members also support the dissemination of findings of patient-centric outcomes through conference presentations, scientific journals, regulatory dossiers, and press releases.

Example research activities include development of conceptual models of disease; the systematic selection of COA instruments to measure concepts of interest; psychometric assessment of the measurement properties of COA instruments; development of novel COA instruments, including the execution of cognitive interviews to ensure content validity; development of briefing books or dossiers for regulatory consideration of COAs for inclusion in product labeling; and faithful migration of COA instruments from paper for electronic use.  Internal customers include global clinical research, global biometric sciences, medical affairs, GHEOR, Worldwide Value Access and Pricing, and Worldwide Commercial.

Responsibilities:

• Ensuring the implementation of optimal COA strategy in relevant protocols. This includes managing research required to support the selection, development, and validation of COA measures, including qualitative research. Provide protocol language, analysis plans, and guides for interpretation of findings.

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

• Support PROA Lead’s initiatives and ensure alignment with objectives of the PROA team

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

• 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

• Prepare abstracts and manuscripts presenting COA results from clinical trials as well as COA development and validation studies that are aligned with publication strategy

• At direction of the Lead of PROA, participate in global external collaborations regarding policies, standards, and use of COA measures (e.g., PRO Consortium, BIO PFDD Task Force, PRO-CTCAE working group, 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.

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

• Experience with application of COA measures in neuroscience

• Experienced with COA requirements for regulatory and HTA/reimbursement agencies, including understanding of