Director, PED Policy & Best Practices
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
The Director, PED Policy & Best Practices, is responsible for monitoring and influencing the patient experience data/patient focused drug development (PED/PFDD) landscape across global regulatory and HTA authorities and driving the development of standards & best practices to elevate research above brand and across therapeutic areas for HEOR and AbbVie in alignment with external policy and methods.
The Director, PED Policy & Best Practices, will cultivate strong partnerships internally to enable effective cross-functional collaboration with Clinical Development, Regulatory, Biostatistics, Regulatory Affairs, and Government Affairs teams. The Director is a scientific leader in the external environment, representing AbbVie at key industry forums and contributing to external dialogue on patient-focused drug developmen and innovative research methods to both monitor and influence external affairs. In addition, the Director will be responsible for managing key external strategic partnerships with key patient-focused research and/or advocacy organizations and industry trade associations (eg, National Health Council, PhRMA & BIO PFDD Working Groups). He / She serves as a leader within HEOR for departmental activities and for other internal AbbVie enterprise-wide initiatives to drive a patient-centric culture and adoption/uptake of standards and best practices for PED. Managerial responsibilities for the Director include attracting, mentoring, and retaining staff.
Core Job Responsibilities:
- Monitor and influence the patient-focused drug development (PFDD) landscape and policy to maintain awareness and influence evolving regulatory and HTA/value assessment requirements
- Serves as internal and external thought leader on patient-focused drug development, regulatory and reimbursement agency guidance and expectations for PED methods and documentation, and mentors other members of staff on policy applications and methodological standards
- Lead development of standards/best practices and process improvement for PED within HEOR and across AbbVie
- Lead/Participate in cross-functional above-brand initiatives (eg, PFDD CoP)
- Lead HEOR’s strategic framework for equality, equity, diversity and inclusion inclusive of talent management strategy to cultivate an inclusive environment for current and future staff, partnership with R&D to enhance diversity in clinical trials, drive research to improve outcomes & access, and identify and advance key strategic partnerships
- Coordinates development of educational resources leveraging deep expertise of PCOR Patient Experience Data & Strategy Team for functions across AbbVie to drive the integration of patient voice in development programs
- External engagement and education with regulatory & measurement KOLs, patient-centric research organizations, HTA/value assessors, and industry consortiums and methodological forums
- Develops and leads efforts for team development and individual mentorship and creates an environment for global exchange, inclusion and collaboration
- Attracts, retains, and mentors top talent to build a highly productive team
Minimum Education & Experience:
- Advanced degree in Psychology, Epidemiology, Statistics, Public Health, Health Economics and Outcomes Research (HEOR) or related discipline (MS, MPH, PharmD, PhD) preferred
- Minimum of 7 years is required with relevant pharmaceutical industry or consulting experience in patient experience data research; clinical outcome assessment / patient reported outcome development, validation, and implementation; and medical product development and trial design
- Extensive knowledge of PFDD policy and trends for inclusion of PED in regulatory, HTA and value assessor decision-making
- Experience in fostering and driving external collaborations and partnerships aligned with corporate objectives
- Ability to translate external insights into opportunity & application within AbbVie for PED
- Excellent interpersonal skills with an ability to understand, respond and influence effectively across multiple internal and external customers
- Executive Presence & Communication Skills
- Ability to work collaboratively to leverage other HEOR capabilities (Strategy, Geographies, other CoEs – Economic Modeling, Meta-Research, RWE Analytics)
- Develop standards and respond quickly to business questions
- Ability to attract, maintain talent & lead high-performing teams
- Travel – Position requires up to 25% travel
Significant Work Activities
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.