Program Director - Data Partner Network (RWE Studies) - NESTcc
The Medical Device Innovation Consortium (MDIC) is the first ever public-private partnership created with the sole objective of advancing medical device regulatory science for patient benefit.
In September 2016, the Food and Drug Administration Center for Devices and Radiological Health (CDRH) awarded MDIC funding to demonstrate the value of real-world evidence (RWE) to patients, manufacturers, payers, and providers. Our work in this area has the potential to redefine how new technologies are developed and evaluated, creating the structures for responsible sharing and efficient analysis of RWE to inform and empower patients, accelerate medical device innovation, and improve healthcare outcomes.
In this high visibility role as the Program Director of the National Evaluation System for health Technology Coordinating Center (NESTcc) Data Network, you will be responsible for the successful launch and growth of the NESTcc Data Network and its ability to support a wider range of research studies for medical devices, imaging, and diagnostic technologies. You will develop the data strategy in accordance with the Strategic and Operational Plan, developing and nurturing relationships with key organizations (health system providers, public and private payers, society and patient registries, and other organizations with access to real-world data).
The mission of NESTcc is to accelerate the development and translation of new and safe health technologies, leveraging RWE and innovative research. The Data Network is launching with an initial set of collaborators who are interested in participating in a device-focused data network, establishing us 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.
Stakeholders across the medical device ecosystem stand to benefit from improved use of RWE generated in the routine course of care. As a membership-based 501(c)3 organization, MDIC brings together representatives of the FDA, National Institutes of Health (NIH), Centers for Medicare & Medicaid Services (CMS), industry, nonprofits, and patient organizations to improve the processes for development, assessment, and review of new medical technologies.
MDIC works on science, not policy. 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.
Key Responsibilities of the Program Director
- 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 collaboratively 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 catalog 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.
Qualifications of the Program Director
- Advanced degree required (D., MD, MBA, or MS) in a related area such as informatics, clinical research, or epidemiology.
- 8-15 years of related professional experience in healthcare, medical technology, or life sciences industry.
- Demonstrated leadership roles managing complex multi-stakeholder interactions.
- Proven ability to think strategically and implement complex solutions within an aggressive timeframe.
- Ability to be flexible and work collaboratively as a team within a dynamic, startup work environment to include virtual teams.
- Ability to travel up to 15%.
- Self-directed, team-player with a sense of humor.
Attributes of the Program Director
- Skilled project manager. Whether it’s something that requires a quick turnaround or a long-term commitment, you take full responsibility from start to finish. When you say you’ll get back to someone, you do. You bring order to competing priorities and keep things running smoothly.
- Collaborative work-style. You share information and coordinate effectively at all levels throughout the organization. You work cooperatively, are able to seek out relevant information, decide the appropriate steps, and facilitate to get the desired results.
- Self-driven and proactive. You ask questions and come up to speed quickly. You are hands-on, dive in, and take initiative without being asked.
- Champion for the mission. You understand the big picture, know what is important to stakeholders, and what best serves the mission. You are a visible advocate, enthusiastically representing all of your organization’s programs and initiatives.
- Highly organized, yet flexible. You know what’s expected of you and you plan carefully to achieve results. You can easily shift gears and reprioritize as needed.
- Effective communicator. You are a superb writer, thinker, and listener. You easily shift gears and reprioritize as needed. You are able to deliver complex information and presentations to a variety of audiences in a credible and presentable way.
- Organizationally agile. You seek out and respect other viewpoints and you share your insights as well. You effectively work across agencies and organizations to build long-standing relationships.
What’s Attractive to the Right Program Director Candidate?
- Your work holds the potential to dramatically advance regulatory science for medical devices, accelerating medical device innovation, leading to better informed and more empowered patients, and improving healthcare outcomes for every American. By helping to re-engineer the tools for innovation and regulatory assessments, you will help address the unsustainable cost trajectory of medical technology innovation, improve patient access and safety, and reduce costs to the healthcare system.
- This high visibility role gives you unique exposure to national leaders in academic and regulatory institutions, health system providers, public and private payers, patient safety advocates, the medical device industry, and everyone interested in providing patients with timely access to high-quality, safe, and effective medical devices.
- Because we are a newly created organization, you will not just be a cog in a wheel, rather, you will have an active voice as a key contributor. We work together and succeed together, and your ideas and input are an integral part of our success.
- With an ever-changing landscape in the healthcare industry, your work will ultimately keep our stakeholders informed and connected to current resources that will better enable them to make important business decisions, share vital resources with each other, and keep up with healthcare trends across the world.
- We offer an excellent compensation package including health, dental, and life insurance, paid time off, 403(B) plan with match, short term and long term disability insurance, and more.
To Apply for the Program Director position with NESTcc:
Use the "Apply" button on this page or simply email your resume to Aileen Hedden at email@example.com with “NESTcc – Program Director / 2018-2329 SA” as the subject of the email.
Alternative Titles: Director of Research, Program Manager, Senior Manager.
Staffing Advisors has been engaged to find the right candidate and is committed to helping create a diverse work environment for our client. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other basis protected by law. This position may require pre-employment screening potentially including a criminal background check, verification of academic credentials, licenses, certifications, and/or verification of work history.