About the Role
Leads the design and execution of clinical studies to support regulatory submissions and product lifecycle management. Collaborates with cross-functional teams to ensure clinical data meets scientific, regulatory, and commercial objectives.
Responsibilities
- Lead the development of clinical strategies for new and existing medical devices
- Design and oversee execution of clinical trials and real-world evidence studies
- Ensure clinical study protocols align with regulatory requirements and scientific standards
- Collaborate with regulatory affairs to prepare submissions and respond to agency inquiries
- Analyze and interpret clinical data to inform product development decisions
- Present clinical findings to internal stakeholders and external partners
- Manage relationships with contract research organizations and key opinion leaders
- Support health economics and outcomes research initiatives
- Guide cross-functional teams on clinical aspects of product labeling and claims
- Monitor clinical study progress and ensure adherence to timelines and budgets
- Ensure compliance with ethical standards and regulatory guidelines
- Contribute to risk assessment and mitigation strategies for clinical programs
- Support post-market clinical surveillance and safety monitoring
- Develop and maintain clinical evaluation reports and documentation
- Advise on clinical input for product training and educational materials
- Participate in due diligence for new technology acquisitions
- Stay current with advancements in clinical research methodologies and regulatory landscapes
- Mentor junior clinical team members and promote scientific excellence
- Coordinate with quality assurance to ensure data integrity and audit readiness
- Facilitate cross-departmental alignment on clinical evidence needs
Compensation
Competitive salary and benefits package
Work Arrangement
Hybrid work model with flexible location options
Team
Part of the clinical research and development team focused on advancing continuous glucose monitoring technologies
Why Join Us
- Opportunity to advance life-changing technology for people with diabetes
- Work in a fast-paced, innovation-driven environment committed to improving patient outcomes
- Access to professional development and leadership growth programs
Location
- Position based in a major U.S. metropolitan area with hybrid work flexibility
- Travel may be required for site visits, conferences, and team meetings
Available for qualified candidates
