Associate Director, Patient-Centered Outcomes Research (Oncology)

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.

Job Description

The Associate 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).

The Associate Director, Patient-Centered Outcomes Research, will support multiple programs across therapeutic areas 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. In addition, the Associate Director will support collaborations with external partners (eg, industry consortiums, key opinion leaders, research organizations, patient advocacy groups). The Associate 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. 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 Associate Director will be responsible for several programs across AbbVies portfolio (eg, spanning multiple products/ indications). Additional responsibilities for the Associate 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.

Responsibilities

• Responsible for execution of global PED evidence 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 innovative patient-relevant outcomes measures and endpoints to differentiate AbbVies 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 (e.g., 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., COA methods, regulatory requirements to obtain COAs on labels, industry trends)
• Develops and delivers standards/best practices and educational resources for functions across AbbVie to drive the integration of patient voice in development programs
  
  
  

Qualifications

• Advanced degree in Psychology, Epidemiology, Statistics, Public Health, Health Economics and
• Outcomes Research (HEOR) or related discipline (MS, MPH, PharmD, PhD) preferred
• Minimum of 5 years of experience required, with relevant pharmaceutical industry or consulting experience in patient experience data 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
• 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 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 Centers of Expertise [CoEs] Economic Modeling, Meta-Research, RWE Analytics)
• Develop standards and respond quickly to business questions
• Travel Position requires up to 15% travel
  
  
  

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible to participate in our short-term incentiveprograms.
• This job is eligible to participate in our long-term incentiveprograms
  
  
  

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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