Director of Clinical Operations

Senseye • Austin, TX

1d

About The Position

Senseye is a NeuroTechnology Company in Austin, TX on the cusp of revolutionizing Mental Health. Over the past 6 years we have invested millions of dollars in R&D to build our platform allowing us to measure cognitive activity via the eye through mobile phones. Through multiple iterations and use cases we are now focused on building the world's first Objective Mental Health Diagnostics on top of our core technology. Our first diagnostic is for PTSD and is entering clinical trials now, followed soon by additional indications for Anxiety and Depression. As the world struggles with a mental health crisis, it is not hyperbolic to suggest that an objective diagnostic platform, that gives clinicians a safe and objective accurate approach to identifying and monitoring mental health disease, will redefine how mental health services are provided and will enable access to treatment for hundreds of millions of sufferers. The Senseye platform has the potential to be the technology that drives this change. We are seeking a highly skilled Software as Medical Device (SaMD) Quality Engineer with substantial experience in SaMD design, development, and medical device quality systems. This pivotal role involves overseeing our AI-enabled SaMD products across the entire lifecycle—from initial development through post-market surveillance, ensuring adherence to all regulatory, quality, and customer requirements. The role title (Engineer or Sr. Engineer) will be commensurate with the candidate's experience level.

Requirements

• Bachelor’s degree in a relevant field (Master’s or PhD preferred)
• 5–8+ years of experience in clinical research, clinical operations, or clinical affairs
• Demonstrated experience leading or managing clinical teams or vendors (e.g., CROs)
• Experience in medtech, digital health, or neurotechnology
• Familiarity with FDA clinical/regulatory pathways
• Strong cross-functional collaboration and communication skills

Nice To Haves

• Experience in mental health or neuroscience
• Background in digital biomarkers or AI-driven diagnostics
• Startup or high-growth company experience
• Experience building or scaling clinical operations functions

Responsibilities

• Lead and execute clinical studies from early validation through pivotal trials
• Oversee and mentor clinical operations team members, fostering strong execution and professional development
• Manage and coordinate external partners, including CROs, sites, and investigators
• Design study protocols and generate evidence to support regulatory and commercial goals
• Collaborate cross-functionally with Research, Artificial Intelligence, and Regulatory teams
• Support FDA submissions and clinical documentation
• Contribute to scientific publications and presentations
• Ensure compliance with GCP and applicable regulations

Benefits

• The freedom and trust to define your role as we design, build, and ship our products
• Competitive salary and stock option plan
• Flexible paid time off (vacation, sick leave, and public holidays)
• Flexible schedules
• Company health care plan
• Medical, dental, and vision insurance
• Short and long term disability insurance
• Life insurance policy
• 401k
• Commuter benefits for parking, public transit, carshares, etc.
• Mothers' room
• Fully stocked kitchen
• Opportunities for continuing education

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 1-10 employees