Director, Clinical Operations

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

Company Overview

Echo Neurotechnologies is an exciting new startup in the Brain-Computer Interface (BCI) space, driving innovation through advanced hardware engineering and AI solutions. Our mission is to deliver cutting-edge technologies that restore autonomy to people living with disabilities and improve their quality of life.

Team Culture

Join a small, dedicated team of knowledgeable and motivated professionals. Our early-stage environment offers the opportunity to take ownership of broad decisions with significant and long-lasting impact. We emphasize continuous learning and growth, fostering cross-functional collaboration where your contributions are vital to our success.

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, elevate 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

Salary

$180,000 - $240,000 USD

What We Offer

• An opportunity to work on exciting, cutting-edge projects to transform patients' lives in a highly collaborative work environment.
• Competitive compensation, including stock options.
• Comprehensive benefits package.
• 401(k) program with matching contributions.

Equal Opportunity Employer

Echo Neurotechnologies is an Equal Opportunity Employer (EOE). We celebrate diversity and are committed to creating an inclusive environment for all employees.

Confidentiality

All applications will be treated confidentially. Applicants may be asked to sign an NDA after the initial stages of the interview process.