Director, Clinical Operations

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

Benefits offered by this job

Stock options

401(k) matching

Competitive compensation

Job summary

Echo Neurotechnologies seeks a Director of Clinical Operations to lead the infrastructure and execution of IDE clinical trials across product lines. You will build a capable team, plan studies from early feasibility to post-market, manage budgets, ensure regulatory compliance, and foster strong investigator relationships.

You will collaborate with Clinical Science, R&D, Product, Regulatory, and Quality to align study strategy with company goals and report progress to executives.

Qualifications

• 10+ years in clinical research
• 5+ years people management experience
• Medical device clinical research experience required
• Class III device experience preferred
• Neurotechnology device experience preferred
• Experience managing IDE studies
• Neuroscience or biomedical engineering background a plus
• Experience managing BCI or DBS studies a strong plus

Responsibilities

• Department infrastructure: select and manage a CTMS/EDC system
• Build right-sized Clinical Operations team (in-house or CROs)
• End-to-end study planning and management from IDE to post-market surveillance
• Manage study budgets and forecasting
• Ensure FDA/IRB/GCP/ISO 14155 compliance
• Build and maintain relationships with KOLs, investigators, and sites
• Manage and mentor Clinical Operations team
• Provide input into clinical and regulatory strategy
• Represent Clinical Operations to Executives with progress metrics
• Partner with Clinical Science,R&D, Product, Regulatory, Quality and others

Skills

Clinical research experience

People management

Medical device trials

IDE studies

Class III devices

Neurotechnology devices

BCI/DBS studies

Neuroscience/Biomedical engineering

Education

Neuroscience or Biomedical engineering background

Job description

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 aDirector 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, escal…


• Partner with Clinical Science, R&D, Product, Regulatory, Quality, and other cross-functional leadership to align study strategy with company goals

QUALIFICATIONS

• 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

$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.

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.