Director, Patient Centered Outcomes Reporting, Oncology

🔥 2 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $160.5k - $305k / year

⏰ Full Time

🔴 Lead

👔 Director

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AbbVie

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2013

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

AbbVie is a global pharmaceutical company that discovers and delivers innovative medicines and solutions to enhance lives. With a focus on addressing the world's toughest health challenges, AbbVie operates in over 175 countries, providing a wide range of products across areas like immunology, oncology, neuroscience, and aesthetics. Committed to scientific innovation, AbbVie invests heavily in research and development, aiming to produce first-in-class medicines. The company also emphasizes workplace diversity, sustainability, and patient support initiatives, ensuring positive impact for both its patients and the broader community.

📋 Description

• Responsible for execution of global PED 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 and validate 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 (eg, 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., psychometric methods and results interpretation, COA methods, regulatory requirements to obtain COAs on labels, industry trends) • Ensure scientific integrity of PED research through serving as expert reviewer on study designs, protocols, results and scientific communications (eg, qualitative or quantitative expert review) • Lead above-brand research projects/initiatives to pilot innovative methodologies and elevate internal standards/best practices (eg, unique data presentation/visualization techniques, psychometric methodologies, digital health technology) • Engages with external thought leaders and representatives at global regulatory and reimbursement authorities to shape the external environment with respect to patient centered outcomes research and patient focused drug development policy in alignment with AbbVie corporate objectives • 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 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 experience required, with relevant pharmaceutical industry or consulting experience in PED 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 • Demonstrated ability in evaluating, developing, and validating COA instruments for inclusion in clinical programs that meet regulatory agency standards for label claims • 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 global 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 CoEs – Economic Modeling, Meta-Research, RWE Analytics) • People management experience • Develop standards and respond quickly to business questions • Travel – Position requires up to 20% travel

🏖️ Benefits

• paid time off (vacation, holidays, sick) • medical/dental/vision insurance • 401(k) • long-term incentive programs