Director, Patient Centered Outcomes

Employer
AbbVie
Location
Lake County, IL, US
Posted
Mar 29, 2019
Ref
1900442
Required Education
Doctorate/PHD/MD
Position Type
Full time

The Director, Patient Centered Outcomes (PCO) will be part of the PCO center of excellence within the Health Economics and Outcomes Research organization and will be responsible for providing critical expertise and guidance on patient-centric research to support the development and commercialization of multiple pipeline and on-market products. The Director will work within cross-functional teams to ensure that patient centricity is employed strategically from early development through commercialization, to help optimize clinical development programs and to promote positive external awareness of the patient value of AbbVie's products.
Key responsibilities:

• Provide strategic leadership and guidance to cross-functional teams on the development and implementation of Patient-Reported Outcomes (PRO), Digital Health Endpoints, Clinical outcomes assessment (COA) and Patient focused drug development (PFDD) strategies

• Shape external environment regarding policy, standards and use of PCO

• Develop innovative patient-centric solutions to bridge clinical trial-based evidence with real-world evidence

• Collaborate with cross functional teams to establish governance process and facilitate best-practice sharing to ensure appropriate patient-focused endpoints are included in product development

• Act as the champion for patient preferences and perspective within drug development teams

• Provide expert guidance to therapeutic area teams on COAs and other measurement issues and lead education efforts within Abbvie and strategic partners

• Provide expertise on preparation of sections of documentation for regulatory and HTA agency meetings, and participate in meetings with agencies; provide robust evidence in support of submission activities

• Develop publication of PCO development, validation and results from clinical trials

 

 

  • Solid understanding of drug development and commercialization, with demonstrated experience integrating patient-centric data through all phases of product life cycle
  • In-depth understanding of (1) relevant regulatory (FDA and EMA) and Health Technology Assessment (HTA) guidances and documents pertaining to inclusion of patient-centric data in regulatory and HTA decisions, as well as (2) critical success factors related to the inclusion of patient-centric data in regulatory and HTA decisions
  • Preferred: PhD in Psychology, Psychometrics, Social Sciences, Health services research, or related field with at least 7 years of relevant experience in a pharmaceutical company or research organization providing services to pharmaceutical companies
  • Will consider: PharmD. or MS in Psychology, Social Sciences, Health services research, or related field with 10 years of relevant experience

 


Equal Opportunity Employer Minorities/Women/Veterans/Disabled