Director, Patient Centered Outcomes Reporting, Oncology

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Accountable for the implementation of global Patient Experience Data (PED) generation and stakeholder engagement strategies that involve innovative research aligned with the overall asset strategy across various therapeutic areas.

• Oversees project management to ensure the timely execution of PED research aimed at characterizing patient outcomes, identifying patient preferences and unmet needs, informing patient-focused measurement strategies, and developing and validating innovative patient-relevant outcome measures and endpoints to differentiate AbbVie’s portfolio and fulfill business and global requirements.

• Facilitates alignment of strategy with Health Economics and Outcomes Research (HEOR) counterparts and communicates strategy while translating results to key cross-functional teams involved in the Pipeline Commercial Model to ensure the integration of PED plans into the broader Integrated Evidence Plans.

• Guarantees the scientific quality and integrity of Clinical Outcome Assessment (COA) research through the creation of rigorous qualitative and quantitative study proposals, protocols, analysis plans, and reports.

• Directs the integration of COA measurement strategy into clinical development programs with support for clinical trial programs (e.g., protocol/SAP content development, results interpretation, and CSR development) and ensures the proper implementation of COAs on electronic COA platforms in global programs.

• Leads the development, validation, and implementation of COA measures for randomized controlled trials (RCTs) and observational studies.

• Takes charge of strategy and content development for regulatory and reimbursement submissions related to PED and patient-relevant endpoints, and leads/participates in discussions and negotiations with regulatory and reimbursement authorities to optimize registration approval, product labeling, promotion, and patient access decisions.

• Crafts a strategic scientific communication plan that includes the submission and presentation of research in peer-reviewed journals and at medical/methodological congresses.

• Acts as an internal Subject Matter Expert (SME) in technical specialty areas to identify new methodologies and advancements in the field (e.g., psychometric methods, results interpretation, COA methods, regulatory requirements for COA labeling, and industry trends).

• Ensures the scientific integrity of PED research by serving as an expert reviewer for study designs, protocols, results, and scientific communications (e.g., qualitative or quantitative expert reviews).

• Leads cross-brand research projects/initiatives to pilot innovative methodologies and elevate internal standards and best practices (e.g., unique data presentation techniques, psychometric methodologies, digital health technology).

• Engages with external thought leaders and representatives from global regulatory and reimbursement authorities to influence the external landscape regarding patient-centered outcomes research and patient-focused drug development policy in alignment with AbbVie’s corporate objectives.

• Develops and provides standards, best practices, and educational resources for functions across AbbVie to promote the integration of patient voices in development programs.

⛳️ Requirements

• An advanced degree in Psychology or Psychometrics, Epidemiology, Statistics, Public Health, Health Economics and Outcomes Research (HEOR), or a related discipline (MS, MPH, PharmD, PhD) is preferred.

• A minimum of 7 years of experience is required, with relevant experience in the pharmaceutical industry or consulting in PED research; clinical outcome assessment/patient-reported outcome development, psychometric validation, and medical product development and trial design.

• Proven ability to evaluate and develop PED from conceptualization through negotiations with global authorities.

• Demonstrated expertise in evaluating, developing, and validating COA instruments for inclusion in clinical programs that satisfy regulatory agency standards for label claims.

• Experience in preparing regulatory and Health Technology Assessment (HTA) submissions.

• Excellent interpersonal skills with the ability to leverage deep expertise to understand, respond, and influence effectively across various internal and external stakeholders.

• Proven capability to manage multiple priorities in a rapidly changing environment.

• Exceptional written and verbal communication skills.

• Experience in delivering services across complex matrix environments at a global level.

• Strong project management abilities.

• Demonstrated knowledge and experience in the pharmaceutical industry (including an understanding of regulatory and compliance frameworks) and clinical trial design.

• Familiarity with global regulatory and HTA requirements for patient-centered endpoints.

• Ability to effectively interpret and communicate research results to both internal and external audiences.

• Capability to collaborate effectively to leverage other HEOR capabilities (Strategy, Geographies, other Centers of Excellence – Economic Modeling, Meta-Research, RWE Analytics).

• Experience in people management.

• Ability to develop standards and respond promptly to business inquiries.

• Travel: This position requires up to 20% travel.

🏝️ Benefits

• Paid time off (vacation, holidays, sick leave).

• Medical, dental, and vision insurance.

• 401(k) plan.

• Long-term incentive programs.