Director, Patient Centered Outcomes Research

Primary Job Function:

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 (eg, Clinical Development & Operations, Regulatory, Commercial).

The Director, Patient-Centered Outcomes Research, will support a therapeutic area and cultivate strong partnerships to enable effective cross-functional collaboration with other product team members from 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.  In addition, the Director will represent AbbVie externally and assume a leadership role in collaborations with external partners (eg, industry consortiums, key opinion leaders, research organizations, patient advocacy groups).  He / She 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 will oversee at least one therapeutic area (eg, oncology, rheumatology, gastroenterology, dermatology, neurosciences, eye care, aesthetics) and their responsibility will span multiple products/ indications. Additional responsibilities for the Director include developing annual strategic planning of PED aligned with TA / asset strategy and managing multiple projects and vendors to execute PED for their respective TA responsibilities. Managerial responsibilities may include attracting, mentoring, and oversight of junior members of the team (eg, interns, fellows, associate directors); development of annual strategic plans aligned with TA / asset strategy and managing annual budgets for their respective TA responsibilities.

Core Job Responsibilities:

• 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.

Minimum Education & Experience

• 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 is 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.

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.