Director/Senior Director, Digital Health and Innovation - Drug Development
As a part of the Development Design Center, the Digital Health and Innovation Director will help clinical teams improve their evidence generation, health outcomes, and patient experience through the adaptation of digital technology in clinical trials. The Director help advance research and innovation in digital health by 1) conduct ongoing digital technology landscape assessments, 2) develop key external partnerships, 3) perform product pilots, 4) help influence external stakeholders such as regulatory agencies, HTAs, advocacy groups, industry trade organizations, and investigators, and 5) work closely with the clinical teams and broader organization to successfully implement digital solutions across the R&D enterprise This position may be filled at the Director or Senior Director level depending on education and experience. Responsibilities: Execution on the Digital Strategy
- Serve as thought leader and trusted business advisor to clinical team leads, making sure that the digital technologies being used are aligned with the overall digital strategy
- Help define the strategic opportunities and challenges which AbbVie could address with new Digital Products (software medical devices, wearables, health apps, etc.).
- The Director will be responsible for the assessment of the rapidly changing digital health technology landscape to keep track of key developments to continually identify innovative ideas, trends and technologies that could provide Abbvie opportunities to hasten and/or amplify the impact of our therapies.
- Help perform the tasks required to incubate innovative digital health solutions and collect data for the assessment, evaluation and implementation of the same to accelerate strategic innovation within R&D
- Provide leadership to therapeutic area teams regarding the development of the Digital health strategy, appropriateness of device selections and leads regulatory efforts to maximize labeling potential
- Ensures endpoint strategies are aligning with the product strategic plans
- Provide expertise on preparation of sections of documentation for regulatory agency meetings and participate in said meetings to facilitate interactions with regulatory and HTA agencies
- Guide therapeutic area teams and scientist on analysis of digital device/wearable data from clinical trials, and publication of results as well as validation studies
- Develop guidance and good practice documents/SOP for digital generated evidence
- The Director will be responsible for develop training material and identify educational opportunities for clinical development leaders on topics relevant to digital health and implementation in RCT.
- Bachelors, Masters or higher degree in health services research, public health or related field with at least 7 - 10+ years of relevant experience in a pharmaceutical industry
- A minimum of 5 years experience implementing digital technologies for clinical trials
- 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 such as regulatory agencies, HTA bodies, and investigators
- Excellent understanding of changing global pharmaceutical, regulatory, and technology environment
- Strong presentation track record