Director, Patient Centered Outcomes Reporting, Oncology

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio.

About the role

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 (e.g., Clinical Development & Operations, Regulatory, Commercial). This role primarily supports Oncology and cultivates strong partnerships to enable effective cross-functional collaboration with internal groups including HEOR-Strategy, Clinical Development and Operations, Biostatistics, Regulatory Affairs, Medical Affairs, and the Commercial organization.

The Director represents HEOR at global regulatory and payer/HTA meetings and may lead and/or support negotiations in collaboration with cross-functional team members to drive internal strategy and alignment with global regulatory & reimbursement agencies. Additionally, the Director will represent AbbVie externally, assuming a leadership role in collaborations with external partners (e.g., industry consortiums, key opinion leaders, research organizations, patient advocacy groups).

This role serves as a subject matter expert (SME) on PED and patient-centered measurement strategies within HEOR and AbbVie to drive a patient-centric culture and adoption/uptake of standards and best practices for PED. The Director oversees at least one therapeutic area (e.g., oncology, rheumatology, gastroenterology, dermatology, neurosciences, eye care, aesthetics) and manages responsibilities spanning multiple products/indications.

Managerial responsibilities may include attracting, mentoring, and oversight of junior team members (e.g., interns, fellows, associate directors), development of annual strategic plans aligned with therapeutic area/asset strategy, and managing annual budgets.

Responsibilities

• Execute global PED generation and stakeholder engagement strategies aligned with overall asset strategy across multiple therapeutic areas.
• Lead 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/validate innovative patient-relevant outcomes measures and endpoints.
• Support alignment of strategy with HEOR-Strategy counterparts and communicate strategy/results cross-functionally to key teams within the Pipeline Commercial Model to facilitate integration of PED plans into broader Integrated Evidence Plans.
• Ensure scientific quality and integrity of COA research through development of rigorous qualitative and quantitative study research proposals, protocols, analysis plans, and reports.
• Lead integration of COA measurement strategy into clinical development programs through clinical trial support (e.g., protocol/SAP content development, results interpretation, and CSR development) and ensure appropriate implementation of COAs on eCOA platforms in global programs.
• Lead development, validation, and implementation of COAs measures for randomized controlled trials (RCTs) and observational studies.
• Lead/contribute to strategy and development of content for regulatory and reimbursement submissions regarding PED and patient-relevant endpoints; participate in regulatory and reimbursement discussions/negotiations to optimize registration approval, product labeling, and patient access decisions.
• Develop strategic scientific communication plans, including submission and presentation of research in peer-reviewed journals and at medical/methodological congresses.
• Serve as internal SME on technical specialty areas to identify new methodologies and advancements in the field (e.g., psychometric methods, COA methods, regulatory requirements for label claims, industry trends).
• Ensure scientific integrity of PED research by serving as an expert reviewer on study designs, protocols, results, and scientific communications (e.g., qualitative or quantitative expert review).
• Lead above-brand research projects/initiatives to pilot innovative methodologies and elevate internal standards/best practices (e.g., data visualization techniques, psychometric methodologies, digital health technology).
• Engage with external thought leaders and representatives at global regulatory and reimbursement authorities to shape the external environment regarding patient-centered outcomes research and patient-focused drug development policy.
• Develop and deliver standards/best practices and educational resources to drive integration of the patient voice in development programs 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 relevant pharmaceutical industry or consulting experience in PED research, clinical outcome assessment/patient-reported outcome development, psychometric validation, and implementation, and medical product development/trial design.
• Demonstrated ability in evaluation and development of PED from conceptualization through negotiations by global authorities.
• Experience in evaluating, developing, and validating COA instruments for inclusion in clinical programs that meet regulatory agency standards for label claims.
• Experience in preparing regulatory and HTA submissions.
• Excellent interpersonal skills with the ability to leverage deep expertise to understand, respond, and influence effectively across multiple internal and external stakeholders.
• Demonstrated ability to manage multiple priorities in a rapidly changing environment.
• Excellent written and verbal communication skills.
• Experience in handling delivery of services across complex matrix environments and on a global level.
• Strong project management skills.
• Demonstrated experience/knowledge of the pharmaceutical industry (including regulatory/compliance frameworks) and clinical trial design.
• Knowledge of global regulatory and 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 (e.g., Strategy, Geographies, other Centers of Excellence – Economic Modeling, Meta-Research, RWE Analytics).
• People management experience.
• Ability to develop standards and respond quickly to business questions.
• Up to 20% travel required; must be a self-starter with a strong desire to see projects achieve commercial success.

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick).
• Medical, dental, and vision insurance.
• 401(k) eligibility.
• Eligibility to participate in long-term incentive programs.