Echo Neurotechnologies

Implantable brain-computer interface enabling communication

Director Clinical Operations

Clinical Research OperationsConfirmed live in the last 24 hours

Full-timeSan Francisco, CA, USA

About the Job

Requirements

A bachelor's degree is required.
At least 10 years of clinical research experience, including at least 5 years in sponsor-side clinical operations.
At least 5 years of people management experience.
Medical device clinical research experience is required.
Experience managing Investigational Device Exemption (IDE) studies is required; Early Feasibility and/or pivotal study experience is preferred.
Neuroscience or biomedical engineering background is a plus.
Experience managing brain-computer interface or deep brain stimulation studies is a strong plus.
Strong project management skills are required.
Strong written and oral communication skills are required.
Ability to travel 25–30% domestically is required.

Responsibilities

Own the infrastructure for and execution of clinical trials across all product lines, including building a team to support multiple simultaneous Early Feasibility Studies for new Class III active implantable devices.
Select and manage a Clinical Trial Management System/Electronic Data Capture System to support multiple IDE clinical trials.
Build a right-sized Clinical Operations team to support upcoming studies, in-house or through contract research organizations.
Oversee execution of multiple clinical programs, from Early Feasibility Study protocol development through post-market surveillance close-out.
Manage study budgets and forecasting.
Promote efficiency through planning, project management, and site support.
Maintain compliance with applicable regulations and standards, including FDA and Institutional Review Board requirements, Good Clinical Practice, and ISO 14155.
Build and maintain relationships with key opinion leaders, investigators, and clinical sites.
Manage and mentor the Clinical Operations team.
Provide input into clinical and regulatory strategy.
Represent Clinical Operations to executive leadership by reporting study progress and metrics, escalating issues, and proposing solutions.
Partner with Clinical Science, Research and Development, Product, Regulatory, Quality, and other cross-functional leaders to align study strategy with company goals.

Desired Qualifications

Class III device experience is strongly preferred.
Neurotechnology device experience is preferred.
Experience managing Early Feasibility and/or pivotal studies of new medical devices is preferred.
Experience managing brain-computer interface or deep brain stimulation studies is a strong plus.

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, 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

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.

Salary 180000 - 240000 USD

About the Company

Echo Neurotechnologies

Implantable brain-computer interface enabling communication

Echo Neurotechnologies creates brain-computer interfaces (BCIs) aimed at helping people with severe neurological disabilities regain abilities such as conversational communication. Its main product is an implantable BCI system that surgically places electrodes on the brain to record neural signals, which are then decoded by software (potentially using AI) to control external devices or generate speech through a digital avatar. This makes it possible for users to interact with computers or robotic limbs by thinking. The company differentiates itself through leadership from Dr. Edward Chang and a focus on clinically translating BCIs for restoration of communication and movement, backed by venture funding from Andreessen Horowitz and a plan to move toward commercialization in a field with players like Neuralink and Synchron. The goal is to bring therapeutic neural implants to patients, enabling restored communication and mobility for those with severe paralysis.

Company size: Not listed
Company stage: Late Stage VC
Total funding: $50M
Headquarters: San Francisco, CA
Founded: 2023

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