Associate Director Patient Experience Data Strategy

The Associate Director Patient Centered Outcomes Research is responsible for the design and of strategicallyfocused 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 PatientCentered Outcomes Research will support multiple programs across therapeutic areas and cultivate strong partnerships to enable effective crossfunctional collaboration with other product team members from internal groups including HEORStrategy 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 crossfunctional 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 patientcentered measurement strategies within HEOR and AbbVie to drive a patientcentric 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. *This position can sit anywhere in the U.S.

Responsibilities

1. Responsible for of global PED evidence generation and stakeholder engagement strategies that encompasses innovative research aligned with overall asset strategy across multiple therapeutic areas
2. Leads management of projects to ensure timely of PED research to characterize patient outcomes identify patient preferences and unmet needs inform patientfocused measurement strategies and develop innovative patientrelevant outcomes measures and endpoints to differentiate AbbVies portfolio and meet business and global needs
3. Supports alignment of strategy with HEORStrategy counterparts and communicates strategy and translates results crossfunctionally to key crossfunctional teams that are part of Pipeline Commercial Model to facilitate alignment and integration of PED plans into the broader Integrated Evidence Plans
4. Ensures the scientific quality and integrity of COA research through development of rigorous qualitative and quantitative study research proposals protocols analysis plans and reports
5. 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
6. Leads/contributes to strategy and development of content for regulatory and reimbursement submissions regarding PED and patientrelevant endpoints and leads/participates in regulatory and reimbursement discussions and negotiations to optimize registration approval product labeling & promotion and patient access decisions
7. Develops strategic scientific communication plan including submission and presentation of research in peerreviewed journals and at medical / methodological congresses
8. 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)
9. 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 patientcentered 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 MetaResearch 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 or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our shortterm incentive programs. 

• This job is eligible to participate in our longterm incentive programs

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion.  It is AbbVies 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 protected veteran or any other legally protected group status.

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