Director, Clinical Operations

SUMMARY

We are seeking a Director of Clinical Operations. In this role, you will own the infrastructure for and execution of clinical trials for all Echo product lines. This includes building a team to support multiple simultaneous Early Feasibility Studies for new Class III active implantable devices. You will own study planning and management ensuring efficiency and compliance with all regulations. You will contribute to study development, site selection, and investigator relationships.

PRIMARY ROLE AND RESPONSIBILITIES

• Department infrastructure
  • Select and manage a Clinical Trial Management System/Electronic Data Capture System to support multiple IDE clinical trials
  • Build right-sized Clinical Operations team to support upcoming studies (either in-house or with CROs)
• End-to-end study planning and management
  • Oversee execution of multiple clinical programs from EFS protocol development to post-market surveillance close-out
  • Manage study budgets and forecasting
  • Ensure efficiency through strong planning, project management, and site support
  • Maintain compliance with all regulations (FDA and IRB requirements, GCP, ISO 14155, and other applicable standards)
  • Build and maintain strong relationships with KOLs, investigators, and sites
• Manage and mentor Clinical Operations team
• Provide input into clinical and regulatory strategy
• Represent Clinical Operations to Executive leadership - report on study progress and metrics, escalate issues, and propose solutions
• Partner with Clinical Science, R&D, Product, Regulatory, Quality, and other cross-functional leadership to align study strategy with company goals

QUALIFICATIONS

• Bachelor’s degree
• 10+ years in clinical research, at least 5 years in industry (sponsor-side) clinical operations
• 5+ years people management experience
• Medical device clinical research experience required
  • Class III device experience strongly preferred
  • Neurotechnology device experience preferred
• Experience managing IDE studies, preferably Early Feasibility and/or pivotal studies of new medical devices required
• Neuroscience or biomedical engineering background a plus
• Experience managing BCI or DBS studies a strong plus

OTHER QUALIFICATIONS

• Thrives in a fast-paced environment with multiple priorities
• Excellent project management skills
• Excellent written and oral communication skills
• Maintains high-performance standards for self and team
• Leads with empathy and creates a supportive environment
• Ability to travel 25-30% domestically