Associate Director – Patient Experience Data & Strategy

Role Overview

• Responsible for execution of global PED evidence 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 innovative patient-relevant outcomes measures and endpoints to differentiate AbbVie’s portfolio and meet business and global needs
• Supports alignment of strategy with HEOR-Strategy counterparts and communicates strategy and translates results cross-functionally to key cross-functional teams that are part of Pipeline Commercial Model to facilitate alignment and integration of PED plans into the broader Integrated Evidence Plans
• 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 (e.g., protocol/SAP content development, results interpretation and CSR development) 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 and leads/participates in regulatory and reimbursement discussions and negotiations to optimize registration approval, product labeling & promotion and patient access decisions
• 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 (e.g., COA methods, regulatory requirements to obtain COAs on labels, industry trends)
• Develops and delivers standards/best practices and educational resources for functions across AbbVie to drive the integration of patient voice in development programs.

Requirements

• Advanced degree in Psychology, Epidemiology, Statistics, Public Health, Health Economics and Outcomes Research (HEOR) or related discipline (MS, MPH, PharmD, PhD) preferred
• Minimum of 5 years of experience required, with relevant pharmaceutical industry or consulting experience in patient experience data research; clinical outcome assessment / patient reported outcome development, psychometric validation, and implementation; and medical product development and trial design
• Demonstrated ability in evaluation & development of PED from conceptualization through negotiations by global authorities
• Experience in preparing regulatory & HTA submissions
• Excellent interpersonal skills with an ability to leverage deep expertise to understand, respond and influence effectively across multiple internal and external customers
• 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 (knowledge of regulatory/compliance frameworks) and clinical trial design
• Knowledge of 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 (Strategy, Geographies, other Centers of Expertise [CoEs] – Economic Modeling, Meta-Research, RWE Analytics)
• Develop standards and respond quickly to business questions
• Travel – Position requires up to 15% travel.

Benefits

• paid time off (vacation, holidays, sick)
• medical/dental/vision insurance
• 401(k)