Director, Patient Centered Outcomes Reporting, Oncology

AbbVie•Ware, MA

15h•$160,500 - $305,000•Hybrid

About The Position

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 Oncology primarily 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.

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
lly, must be a self- starter and have a strong desire to see projects achieve commercial success.

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