Head of Study Operations

Nudge • San Francisco, CA

23h

About The Position

At Nudge, our mission is to develop the best technology for interfacing with the brain to improve people's lives. We're starting with an approach that we believe can help the most people the fastest, and also allow us to learn as much about the brain as possible: developing a non-invasive, ultrasound-based device that can stimulate and image the brain at high resolution and depth. This is a vertically integrated effort building cutting-edge hardware, software, and research capabilities to create products that can benefit millions — and eventually billions — of people.
To succeed, we need to assemble world-class teams across everything we do. We hire people who are exceptional at their craft, believe hard things are worth doing, and execute relentlessly — people who expect the highest levels of both rigor and integrity from each other.

Requirements

• 10+ years of experience in clinical study roles in the medical device industry, with time spent on therapeutic or neuromodulation devices
• Professional or academic background in neurology, neurosurgery, or brain stimulation clinical research
• Experience designing and running clinical studies, including protocol development, IRB management, and working with clinical sites and CROs
• Track record of building clinical research teams and systems, ideally at a company going from early-stage to first-in-human or commercial launch
• Strong technical first principles (you can engage deeply with engineers and scientists on device design, safety, and performance)
• Bias toward action and ownership; comfortable operating with ambiguity in a fast-paced startup environment
• Excellent written and verbal communication
• High integrity and strong professional judgement

Responsibilities

• Design, plan, and oversee clinical studies from early feasibility through pivotal trials, including protocol design, site selection, IRB submissions, and data management
• Hire and lead a clinical operations team as the company scales
• Partner with research and engineering to integrate clinical and regulatory requirements into product design from the earliest stages
• Manage clinical operations including CRO relationships, clinical site management, and monitoring
• Contribute to the regulatory strategy for Nudge’s transcranial focused ultrasound platform, including FDA submission pathway (De Novo, 510(k), PMA, or Breakthrough Device designations as appropriate)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed