Director, Patient Centered Outcomes
The Director, Patient Centered Outcomes (PCO) will be part of PCO center of excellence and will be responsible for providing expertise and guidance to multiple pipeline and on-market product teams. Ensures endpoint strategies are aligning with the product strategic plans from matrix teams to achieve AbbVie's vision of patient centricity. Provide strategic leadership to therapeutic area teams regarding the development of the PCO strategy, appropriateness of tools and leads regulatory efforts to maximize labeling potential.
• Key part of center of excellence focused on Patient Centered Outcomes that provides leadership to multiple therapeutic areas and representative HEOR scientist to help achieve efficiencies in planning , implementation of Patient-Reported Outcomes (PRO)/ clinical outcomes assessment (COA) and Patient focused drug development (PFDD) strategies.
• Ensure developed PCO strategies are in alignment with clinical, health outcomes and commercial strategies and the overall development plans
• Collaborate with cross functional teams to establish governance process to facilitate best practice sharing and ensure appropriate selection and inclusion of patient reported endpoints in product development
• Provide expert guidance to therapeutic area teams on PROs and other measurement issues and lead education efforts within HEOR, Abbvie and strategic partners
• Provide expertise on preparation of sections of documentation for regulatory agency meetings, and participate in said meetings at regulatory agencies such as FDA, and provide robust evidence in support of submission activities
• Guide therapeutic area teams and scientist on publication of PCO results from clinical trials, and PCO development and validation studies.
• Influences external efforts to shape environment regarding policy, standards and use of PCO.
*Position can be remote
• Preferred: PhD in Psychology, Psychometrics, Social Sciences or Health services research or related field with at least 7 years of relevant experience in a pharmaceutical or a CRO's
• Will consider: MS, or PharmD in Psychology, Social Sciences or Health services research or related field with 10 years of relevant experience
• Significant experience in pharmaceuticals or CRO's dealing with pharmaceutical companies with strong understanding of drug development process, with demonstrated experience in seeing assets progress through the pipeline
• In depth understanding of the FDA guidance and Understanding of critical success factors and obstacles impacting PCO information in successful regulatory label negotiations