Associate Director, Digital Health Strategy
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.
AbbVie’s Digital Science Team is a novel capability team with a unique blend of medical knowledge, digital technologies, regulatory and data science expertise that lead the development and validation of digital health solutions to objectively measure aspects of diseases, detect treatment benefits, unlock new value for our portfolio, and drive the future of the business. As a part of AbbVie’s Digital Science Team, you will have the opportunity to shape the future of medicine development with Digital Health solutions. The Digital Health Strategist serves a key strategic leadership role in the asset strategy teams. You will be responsible to define digital strategy, drive the development and validation of digital measurements, lead the evidence generation, and bring digital strategies to life in meaningful ways for AbbVie and patients. You will also represent AbbVie and contribute to industry trade and consortia collaboration to foster the adoption of digital solutions.
- Identify asset strategy needs and define digital strategy accordingly. Collaborate with asset teams, medical colleagues, and Therapeutic Areas to implement digital strategies, align to asset strategy and generate high-quality evidence suitable to support decision making, label enhancement, or market access.
- Lead analytical validation studies of digital tools, adhere to PFDD, DDTQ, CTTI guidance as well as other relevant federal and international regulations, including GCP, ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards. Stay abreast of new and evolving regulations, guidelines and policies related to digital health and clinical development
- Establish external presence and thought leadership in the field of digital medicine, algorithm development and clinical decision support tools validation with peer-review journal publications, presentations at global congresses.
- Help influence external stakeholders such as regulatory agencies, HTAs, advocacy groups, consortia, industry trade organizations, and investigators.
- Manage multiple digital projects with people and project management skills, e.g. create project plans, value/KPI trackers, monitor scope, budget, timeline, and report milestones/progress.
- Author digital strategy plans, digital data analysis plans, sections of CSR, technical reports, and support publications and presentations.
- Provide SME input on the sections of documentation for regulatory agency meetings. Participate in said meetings to address technical questions raised by regulatory agencies.
- Responsible for mentoring and coaching junior and/or supportive matrix team members and ensure the proper methodologies and scientific rigor are applied to deliver high-quality results.
- Identify business needs and develop guidance, SOPs, and good practice documents. Support/create training, workshops and educational webinars to help establish a knowledge base of digital health and digital endpoint development and strategy within AbbVie.
- BS required. Graduate training preferred.
- PhD with typically 6+ years, MS with typically 8+ years, or BS with typically 10+ years or relevant experience.
- 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 digital endpoints, critical success factors and obstacles impacting device driven outcomes in successful regulatory label negotiations
- Excellent understanding of changing pharmaceutical, regulatory, and technology environment
- Supervisory experience preferred.
- Trusted team leader with people and navigation skills
- Strong ability to collaborate with cross functional matrix teams and external experts to influence strategies
- Expert communication and presentation skills
- Ability to influence key stakeholders such as leadership teams, regulatory agencies, HTA bodies and investigators
- Methodical, detail-oriented, critical thinker with value-evidence mindset and problem-solving skills
Significant Work Activities
Yes, 5 % of the Time
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.