Director of Clinical Operations – Structural Heart
Location: Maple Grove, MN (onsite)
Tricardia is working with a structural heart medical device company to hire an experienced Director of Clinical Operations to lead the operational execution of its FDA IDE pivotal trial for a novel transcatheter mitral valve therapy.
This is a unique opportunity to join a growing, venture-backed organisation at a critical stage of development, working alongside an experienced leadership team to help bring a transformative therapy to patients.
The Role
As Director of Clinical Operations, you'll lead the day-to-day execution of the pivotal clinical trial, ensuring investigator sites remain compliant, patients are successfully enrolled and followed, and the study progresses on schedule. You'll work cross-functionally with Clinical Affairs, Medical Affairs, Regulatory, Quality, Data Management and physician investigators to deliver a successful FDA IDE programme.
This is a hands-on leadership role suited to someone who enjoys solving operational challenges, building strong site relationships and driving clinical trial performance.
An ideal candidate will have:
- 10+ years of Clinical Operations experience within the medical device industry
- Direct experience supporting FDA IDE pivotal clinical trials
- Structural Heart experience is essential
- Previous leadership experience managing Clinical Operations teams
- Strong knowledge of FDA regulations, ICH-GCP and ISO 14155
- Experience partnering with investigators, CROs and cross-functional teams
- A proactive, collaborative approach with the ability to thrive in a fast-paced start-up environment
Why Join?
- Lead the execution of a pivotal FDA IDE trial for an innovative transcatheter mitral valve therapy
- Join a well-funded, growing structural heart company at a key stage of clinical development
- Work alongside an experienced executive leadership team with significant influence over the success of the programme
- Play a central role in bringing a breakthrough therapy closer to commercialisation