Synova Partners · 14 hours ago
Director Clinical Operations - Structural Heart
United States
Full-time
Remote
Director/Executive
8+ years expSynova Partners is a Series A VC backed company, and they are seeking a Director of Clinical Operations for their Structural Heart division. The role involves strategic leadership of clinical activities, overseeing trials, managing site relationships, and ensuring regulatory compliance.
Staffing & Recruiting
Hiring Manager
James Gillman
Responsibilities
Serve as the lead for the company’s clinical programs
Lead the creation and review of core clinical documents (protocols, IBs, ICFs)
Engage and build relationships with KOLs, investigators, and advisors
Manage early feasibility and FIH studies in the US and Europe
Oversee site selection, feasibility assessments, and site engagement
Manage CROs, monitors, and external vendors (e.g., data management, core labs)
Manage patient screening process along with the internal heart team
Ensure compliance with GCP, FDA IDE regulations, and EU MDR/ISO 14155
Track study progress, patient enrolment, data quality, and milestone achievement
Ensure proper documentation (Trial Master File, monitoring reports, etc.)
Hands on guidance and training of new operators
Coordinating device logistics to the sites
Work closely with Regulatory, R&D, and Quality Assurance teams
Collaborate with the executive and technical teams to align strategy and execution
Provide clinical insight into product development and risk assessments
Contribute to clinical content for FDA IDE submissions, EU approvals, and IRB/EC communications
Assist in preparing responses to regulatory queries and inspections
Qualification
Required
8+ years of experience in medical devices, with combined medical and clinical operations roles
Proven track record managing First-in-Human or EFS trials in the US and EU
Strong understanding of clinical trial regulations (FDA, GCP, ISO 14155, MDR)
Hands-on experience managing CROs and global clinical sites
Excellent leadership, communication, and cross-cultural collaboration skills
Startup experience or comfort in lean, fast-paced environments
Willingness to travel (domestic and international) as needed
Preferred
Cardiology/Electrophysiology background strongly preferred
Company
Synova Partners
At Synova our mission is simple; to build high-performing teams for early-stage MedTech companies, empowering them to fulfil their goal of bringing life-saving innovation to the market.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase