Director, Patient Centered Outcomes Research, Oncology

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 and assume 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 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 multiple products/indications. Managerial responsibilities may include mentoring and oversight of junior team members, developing annual strategic plans, and managing 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.
• Ensure scientific quality and integrity of COA research through development of rigorous qualitative and quantitative study proposals, protocols, analysis plans, and reports.
• Lead integration of COA measurement strategy into clinical development programs, including protocol/SAP content development, results interpretation, and CSR development.
• Ensure appropriate implementation of COAs on eCOA platforms in global programs.
• Lead development, validation, and implementation of COAs for randomized controlled trials (RCTs) and observational studies.
• Contribute to strategy and development of content for regulatory and reimbursement submissions regarding PED and patient-relevant endpoints; lead/participate in discussions and 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).
• Ensure scientific integrity of PED research through expert review of study designs, protocols, results, and scientific communications.
• 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 policy around patient-centered outcomes research and patient-focused drug development.
• Develop and deliver standards, best practices, and educational resources to drive integration of the patient voice in development programs.

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, including clinical outcome assessment/PRO development, psychometric validation, and implementation, as well as medical product development and trial design.
• Demonstrated ability in evaluating and developing PED from conceptualization through negotiations with 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 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.
• Knowledge of the pharmaceutical industry (regulatory/compliance frameworks) and clinical trial design.
• Knowledge of global regulatory and HTA requirements for patient-centered endpoints.
• Ability to interpret and communicate research results to diverse audiences.
• Ability to collaborate effectively to leverage other HEOR capabilities (e.g., Strategy, Geographies, Economic Modeling, Meta-Research, RWE Analytics).
• People management experience.
• Ability to develop standards and respond quickly to business questions.
• Up to 20% travel required.

Benefits

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