Director, Patient Centered Outcomes Research, Oncology
AbbVie
Summary
The Director, Patient Centered Outcomes Research, is responsible for the design and execution of strategically-focused and innovative patient experience data (PED) evidence to support optimization of product registration, access & reimbursement, and clinical practice in collaboration with HEOR Strategy and other functions (eg, Clinical Development & Operations, Regulatory, Commercial). The Director will support Oncology primarily and cultivate strong partnerships to enable effective cross-functional collaboration with other product team members from internal groups including HEOR-Strategy, Clinical Development and Operations, Biostatistics, Regulatory Affairs, Medical Affairs, and the Commercial organization.
Job description
Responsibilities
- Responsible for execution of global PED generation and stakeholder engagement strategies that encompasses innovative research aligned with overall asset strategy across multiple therapeutic areas
- Leads management of projects to ensure timely execution of PED research to characterize patient outcomes, identify patient preferences and unmet needs, inform patient-focused measurement strategies, and develop and validate innovative patient-relevant outcomes measures and endpoints
- Supports alignment of strategy with HEOR-Strategy counterparts and communicates strategy and translates results cross-functionally to key cross-functional teams
- Ensures the scientific quality and integrity of COA research through development of rigorous qualitative and quantitative study research proposals, protocols, analysis plans and reports
- Leads integration of COA measurement strategy into clinical development programs through clinical trial program support and ensures appropriate implementation of COAs on eCOA platforms in global programs
- Leads development, validation, and implementation of COAs measures for randomized controlled trials (RCTs) / observational studies
- Leads/contributes to strategy and development of content for regulatory and reimbursement submissions regarding PED and patient-relevant endpoints
- Develops strategic scientific communication plan including submission and presentation of research in peer-reviewed journals and at medical / methodological congresses
- Serves as internal SME on technical specialty areas to identify new methodologies and advancements in the field
- Lead above-brand research projects/initiatives to pilot innovative methodologies and elevate internal standards/best practices
- Engages with external thought leaders and representatives at global regulatory and reimbursement authorities
- Develops and delivers standards/best practices and educational resources for functions across AbbVie
Qualifications
- Advanced degree in Psychology or Psychometrics, Epidemiology, Statistics, Public Health, Health Economics and Outcomes Research (HEOR) or related discipline (MS, MPH, PharmD, PhD) preferred
- Minimum of 7 years of experience required, with relevant pharmaceutical industry or consulting experience in PED research
- Clinical outcome assessment / patient reported outcome development, psychometric validation, and implementation
- Medical product development and trial design
- Demonstrated ability in evaluation & development of PED from conceptualization through negotiations by global authorities
- Demonstrated ability in evaluating, developing, and validating COA instruments for inclusion in clinical programs that meet regulatory agency standards for label claims
- Experience in preparing regulatory & HTA submissions
- Excellent interpersonal skills
- Demonstrated ability to manage multiple priorities in rapidly changing environment
- Excellent written and verbal communication skills
- Experience in handling delivery of services across complex matrix environments and on a global level
- Excellent project management skills
- Demonstrated experience / knowledge of the pharmaceutical industry and clinical trial design
- Knowledge of global regulatory & HTA requirements for patient-centered endpoints
- Ability to effectively interpret and communicate research results
- Ability to work collaboratively to leverage other HEOR capabilities
- People management experience
- Travel – Position requires up to 20% travel
Requirements
- Advanced degree in Psychology or Psychometrics, Epidemiology, Statistics, Public Health, HEOR or related discipline (MS, MPH, PharmD, PhD) preferred
- Minimum of 7 years of experience required
- Relevant pharmaceutical industry or consulting experience in PED research
- Clinical outcome assessment / patient reported outcome development, psychometric validation, and implementation
- Medical product development and trial design
- Demonstrated ability in evaluation & development of PED from conceptualization through negotiations by global authorities
- Demonstrated ability in evaluating, developing, and validating COA instruments for inclusion in clinical programs that meet regulatory agency standards for label claims
- Experience in preparing regulatory & HTA submissions
- Excellent interpersonal skills
- Demonstrated ability to manage multiple priorities in rapidly changing environment
- Excellent written and verbal communication skills
- Experience in handling delivery of services across complex matrix environments and on a global level
- Excellent project management skills
- Demonstrated experience / knowledge of the pharmaceutical industry and clinical trial design
- Knowledge of global regulatory & HTA requirements for patient-centered endpoints
- Ability to effectively interpret and communicate research results to internal and external audiences
- Ability to work collaboratively to leverage other HEOR capabilities
- People management experience
- Travel up to 20%
Benefits
- Paid time off
- Medical, Dental & Vision
- 401(k)
- Long-term incentive programs
Company overview
AbbVie is a global biopharmaceutical company that discovers, develops, and markets advanced therapies for some of the world's most complex and serious diseases. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie has established itself as a leader in immunology, oncology, neuroscience, eye care, and virology. The company's flagship product, Humira (adalimumab), was one of the world's top-selling drugs for treating autoimmune conditions like rheumatoid arthritis and Crohn's disease. AbbVie maintains a robust pipeline of innovative medicines and has expanded its portfolio through strategic acquisitions, including Allergan in 2020. With research facilities across the United States and globally, AbbVie focuses on advancing science to improve patient outcomes while maintaining strong commercial operations worldwide. The company operates with a patient-centric approach and invests significantly in research and development to address unmet medical needs across multiple therapeutic areas.