The Manager, HEOR works independently while under the supervision of the Director to develop and execute outcomes research to demonstrate the value of AbbVie’s products both globally and for the U.S. market. He/She develops outcomes research plans outlining the strategic approach for generating required evidence and research outputs, which may span multiple product / indications. This research includes: creation of economic models (budget impact and cost effectiveness), conduct of claims analyses and observational research studies / analyses, and the development and validation of Patient Reported Outcomes (PRO) measures, and analyses of PRO data. In addition, he/she leads completion of systematic literature reviews, meta-analyses, and U.S. / Global evidence dossiers. This is accomplished through cross-functional collaboration with internal groups including Clinical Development and Operations; Epidemiology; Regulatory Affairs; Medical Affairs; Commercial; and Global / Regional Pricing and Reimbursement. He/She presents health outcomes research findings internally to AbbVie and externally via the peer-reviewed process. In addition, the Manager builds research relationships with key clinical and outcomes thought leaders, resulting in research collaboration.
The employee must conduct their work activities in compliance with all AbbVie internal requirements and with all applicable regulatory requirements. Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements, and objectives.
- Develops conceptual framework for economic model and required analysis to populate model
- Creates and / or manages the creation of the economic model and supporting material
- Manages creation and revisement of Outcomes Research Plan (e.g., strategic imperatives, value messages, research priorities)
- Synthesizes data in the creation of value messages for use in dossiers
- Conducts research gap analysis, drafts / revises protocol synopsis, develops statistical analysis plan
- Leads development, validation, submission, licensing, and administration of Patient Reported Outcomes (PRO) measures for randomized controlled trials (RCTs) / observational studies
- Identifies and assesses research gaps and objectives / studies across key partners and therapeutic areas (TAs) to determine appropriate outcomes research strategy, research objectives, studies, and tactical plan
- Establishes and manages strategy and execution for product / indication Outcomes Research Plan (includes research, dossier, and communication plans) with oversight of the Director
- Represents Global Health Economics and Outcomes Research (GHEOR) on various cross-functional teams (e.g., Clinical Development, Global / Regional Marketing and Global / U.S. payer teams) for multiple product / indications
- Manages strategy and execution for primary / secondary data collection, economic modeling, and PRO research for multiple product / indications
- Manages and conducts evidence generation and documentation (e.g., gap analysis strategy, model scope and framework, protocol synopsis, study reports, and stakeholder training and communications)
- Participates in Advisory Boards and interfaces with top thought leaders to conduct research
- Develops and manages publication creation, review / approval, submission and presentation of research in peer-reviewed journals and at medical / methodological congresses
- Drives translation and quality check of PRO Instrument and Clinical Research Form (CRF)
- Provides support to the department on health outcomes technical specialty areas (e.g., economic modeling techniques to ensure health technology assessments (HTAs) needs are met globally, PRO methods, and understanding regulatory requirements to obtain PROs on labels)
- Helps anticipate and lead development of strategies and tactics to support department operational needs
- Masters degree/fellowship in health economics or related discipline required, however PhD is preferred. Professional training in a health field (MD,PharmD, etc.) is a plus
- Firmly grounded in the scientific fundamentals of one or more of the core HEOR specialties (epidemiology, biostatistics, patient reported outcomes, health services research, economics, clinical practice or behavioral science).
- Capable of performing health economic projects from inception through publication and application with minimal oversight.
- Proven track record of strategic thinking, operational excellence and good communication skills.
Significant Work Activities: N/A
Travel: Yes, 20 % of the Time
Job Type: Experienced