Associate Director, Patient-Centered Outcomes Research (Oncology)

Role Summary

The Associate Director, Patient Centered Outcomes Research (Oncology) 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. This role supports multiple programs across therapeutic areas, fosters cross-functional collaboration, and represents HEOR in global regulatory and payer/HTA meetings. The position develops strategic PED planning aligned with asset strategy and manages multiple projects and vendors within their therapeutic area responsibilities.

Responsibilities

• 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‚Äôs 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

Qualifications

• 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] ‚Äì Economic Modeling, Meta-Research, RWE Analytics)
• Develop standards and respond quickly to business questions
• Travel ‚Äì Position requires up to 15% travel

Education

• Advanced degree in a relevant field; healthcare or life sciences emphasis preferred