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The Medical Device Innovation Consortium (MDIC) is the first-ever 501(c)3 public-private partnership created with the sole objective of advancing medical device regulatory science for patient benefit. As a membership based organization, MDIC brings together representatives of the Food and Drug Administration (FDA), National Institutes of Health (NIH), Centers for Medicare & Medicaid Services (CMS), industry, non-profits, and patient organizations to improve the processes for development, assessment, and review of new medical technologies. Our work is unique and complementary to trade associations such as the Advanced Medical Technology Association (AdvaMed) and the Medical Device Manufacturers Association (MDMA). Members of MDIC share a vision of providing U.S. patients with timely access to high-quality, safe and effective medical devices.
In September 2016, the FDA awarded a grant for the National Evaluation System for health Technology (NEST) Coordinating Center (NESTcc) to MDIC. The mission of NESTcc is the creation of structures for responsible sharing and efficient analysis of real-world evidence to inform and empower patients, accelerate medical device innovation, and improve health care outcomes. Stakeholders across the medical device ecosystem stand to benefit from improved use of real-world evidence (RWE) generated in the routine course of care.
The Director of the NESTcc Data Network will be responsible for the overall successful launch and growth of the NESTcc Data Network and its ability to progressively support a wider, and more exhaustive, range of research studies for medical devices, imaging, and diagnostic technologies.
The NESTcc Data Network director will continue to build, develop and maintain the NESTcc Data Network relationships with key organizations interested in participating in a device focused data network. Organizations may include health system providers, public and private payers, society and patient registries and other organizations with access to real world data supporting the mission of NESTcc. The person will continue to develop the data strategy in accordance with the NESTcc Strategic and Operational Plan for 2018-2022.
The NESTcc Data Network is anticipated to launch in Spring 2018 with an initial set of collaborators. The establishment of the NESTcc Data Network is one of the key strategies for NESTcc as it establishes itself as the leading organization within the health technology and medical device ecosystem for conducting efficient and timely high-quality RWE studies throughout the total product life cycle (TPLC).
As a member of the MDIC team, the individual contributes to the general advancement of the MDIC mission and goals through the work to establish NESTcc. The mission of NESTcc is to accelerate the development and translation of new and safe health technologies, leveraging real-world evidence, and innovative research. This position will have exposure to national leaders in the patient, medical device industry, academic and regulatory institutions and organizations.
Objectives and Responsibilities
- Lead the management of existing relationships with Network collaborators and develop new relationships to expand the scale of the Network.
- Lead the development and execution of agreements between participating organizations and MDIC.
- Work collaborative with the relevant NESTcc subcommittees to achieve subcommittee objectives in alignment with NESTcc strategy. This includes collaborating with the NESTcc Data Quality Subcommittee to ensure NESTcc Data Quality standards are being developed for use and developing processes for implementation of the standards to ensure Network Collaborators are meetings the NESTcc Data Quality Standards. This will also include working with the Methods Subcommittee to ensure high quality methodological standards are being met in studies associated with NESTcc.
- Lead activities related to the Demonstration Projects, to catalogue and disseminate lessons learned, challenges, and solutions with respect to use of real-world data to support device studies.
- Lead activities related to testing the NESTcc Data network, such as the initial test-cases being implemented with the Network Collaborators.
- Lead the development of approaches and resources to streamline the administrative burden associated with contracting, IRB, Data-Sharing agreements, and publication policies for the parties working with the NESTcc.
- As appropriate, lead reporting to the NESTcc Governing Committee and the MDIC Board.
- Work collaboratively with the NESTcc team to meet aggressive timelines to achieve the objectives in the NESTcc Strategic and Operational Plan.
- Manage staff as needed.
- Advanced degree required (PhD, MD, MBA, or MS) in related area such as informatics, clinical research, or epidemiology
- 8-15 years of related professional experience in health care, MedTech, or Life Science industry
- Demonstrated leadership roles managing complex multi-stakeholder interactions
- Proven ability to think strategically and implement complex solutions within an aggressive timeframe
- Highly organized, detail-oriented and takes initiative
- Outstanding presentation and writing skills
- Proven ability to lead multiple, ongoing projects in a fast-paced environment
- Exercise good judgment, and quickly identify and resolve problems
- Ability to be flexible and work collaboratively as a team within a dynamic, start-up work environment to include virtual teams
- Experience working with virtual teams is a plus
- Some travel required
- Self-directed, team-player with sense of humor
The employee will report to the NESTcc Executive Director.
Minimum Education Required
How To Apply
Please send resume and cover letter to email@example.com. Include the position title in the subject line of the email. Resumes will be reviewed on a rolling basis until the position is filled. No phone calls please. Only qualified candidates will be contacted by MDIC.