Overview

About AbbVie
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 . on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Introduction:

As a part of AbbVie’s Digital Health Function, you will have the opportunity to shape the future of drug development. The Digital Health team is responsible for setting the strategic vision for Digital Health across the Development Organization and working across all Therapeutic Areas to bring those strategies to life in meaningful ways for AbbVie and for patients. The Director, Digital Health Strategy will be responsible for setting the digital health strategy and roadmap for digital endpoints development.

Responsibilities:

  • As part of the Integrated Evidence Strategy Team, work closely with GDLs and asset strategy team leads on developing an integrated evidence strategy. When applicable, develop digital strategy plans in support of asset strategy and define value, opportunities, and challenges that AbbVie can solve with new digital health tools.
  • Provide thought leadership and serve as a trusted business partner to TA, clinical team leads, and all functional partners regarding the development and execution of digital health strategies, making sure device selection criteria, validation planning, protocol design, implementation, data analysis, report are well aligned and coordinated to maximize the value evidence and labeling potential.
  • Conduct validation studies, including analytical and/or clinical, and overseeing digital health tools testing, simulation, modeling, algorithm development, patient experience, data analysis, reports, publications, etc.
  • Provide SME input on the sections of documentation for regulatory agency meetings and participate in said meetings to address technical questions raised by regulatory agencies.
  • Help influence external stakeholders such as regulatory agencies, HTAs, advocacy groups, industry trade organizations, and investigators.

Qualifications

  • Bachelor’s degree required, Preferred: Masters or higher degree in health services research, public health or related field with at least 10 years of relevant experience in a pharmaceutical industry
  • Solid understanding of the drug development process, with demonstrated experience in seeing assets progress through the pipeline
  • An understanding of the regulatory requirements for new endpoints, critical success factors and obstacles impacting device driven outcomes in successful regulatory label negotiations
  • Strong ability to collaborate with cross-functional matrix teams and external experts to influence strategies
  • Ability to influence key external stakeholders like regulatory agencies, HTA bodies and investigators
  • Excellent understanding of the changing pharmaceutical, regulatory, and technology environment
  • Strong presentation and communication skills

Significant Work Activities
N/A
Travel
Yes, 5 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
D
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.Tracking

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