Director Medical Affairs & Clinical Operations

Position Summary:

The Director of Medical Affairs & Clinical Operations will be responsible for the strategic, scientific, and operational leadership of all clinical activities. This includes designing and overseeing First-in-Human trials, managing clinical site relationships, ensuring regulatory compliance, and coordinating with internal and external stakeholders across geographies. The ideal candidate combines deep medical expertise, hands-on clinical trial experience, and a startup mindset.

Key Responsibilities:

?? Medical Affairs

• Serve as the medical lead for the company’s clinical programs
• Guide clinical strategy, study design, and protocol development
• Lead the creation and review of core clinical documents (protocols, IBs, ICFs)
• Engage and build relationships with KOLs, investigators, and advisors
• Represent the company at scientific meetings, conferences, and advisory boards – per CEO request

?? Clinical Operations

• 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 enrollment, 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

?? Cross-Functional Collaboration

• Work closely with Regulatory, R&D, and Quality Assurance teams
• Collaborate with the Israeli-based executive and technical teams to align strategy and execution
• Provide clinical insight into product development and risk assessments

?? Regulatory Support

• Contribute to clinical content for FDA IDE submissions, EU approvals, and IRB/EC communications
• Assist in preparing responses to regulatory queries and inspections

Qualifications:

• MD, DO, or equivalent required; cardiology/electrophysiology background strongly preferred
• 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