Director, Clinical Operations – Medical Devices & Neurotech

echo; San Francisco (CA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Stock options

Comprehensive benefits

401(k) with matching

Competitive compensation

Job summary

Echo Neurotechnologies in San Francisco seeks a Director of Clinical Operations to build and run the infrastructure for clinical trials across product lines, including Early Feasibility Studies for Class III devices.

You will lead planning, budgeting, site relationships, and ensure regulatory compliance with FDA/IRB/GCP/ISO standards, while mentoring the Clinical Operations team and partnering with R&D, Regulatory, and Quality.

Qualifications

• 10+ years in clinical research, with at least 5 years in sponsor-side clinical operations.
• 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.
• Neuroscience or biomedical engineering background a plus.
• Experience managing BCI or DBS studies a strong plus.

Responsibilities

• Oversee department infrastructure for Clinical Operations.
• Select and manage a Clinical Trial Management System/Electronic Data Capture to support IDE trials.
• Build a right-sized Clinical Operations team, in-house or with CROs.
• Lead end-to-end study planning and management.
• Oversee execution of multiple clinical programs from IDE protocol development to post-market surveillance close-out.
• Manage study budgets and forecasting.
• Ensure efficiency through planning, project management, and site support.
• Maintain compliance with FDA, IRB, GCP, ISO 14155 and related standards.
• Foster relationships with KOLs, investigators, and sites.
• Mentor Clinical Operations staff and contribute to regulatory strategy.
• Report study progress and metrics to Executive leadership and propose solutions.
• Collaborate with Clinical Science, R&D, Product, Regulatory, Quality, and other functions to align strategy.

Skills

Clinical operations leadership

People management

Regulatory knowledge

IDE studies management

Neurotechnology experience

Education

Bachelor's degree

Job description

Echo Neurotechnologies in San Francisco seeks a Director of Clinical Operations to build and run the infrastructure for clinical trials across product lines, including Early Feasibility Studies for Class III devices.

You will lead planning, budgeting, site relationships, and ensure regulatory compliance with FDA/IRB/GCP/ISO standards, while mentoring the Clinical Operations team and partnering with R&D, Regulatory, and Quality.