Director, GHEOR Patient-Reported Outcomes Assessment (PROA) - Hematology/Oncology

About the position

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

Requirements

• 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.
• The candidate should possess a 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 hematology and oncology 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 hematology/oncology 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.

Benefits

• Medical, pharmacy, dental and vision care.
• Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
• Financial well-being resources and a 401(K).
• Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
• Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
• Parental, caregiver, bereavement, and military leave.
• Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
• Other perks like tuition reimbursement and a recognition program.