Clinical Operations Lead

The Role

This is the person who makes sure we can actually run studies with human participants.

Arbor's human studies use functional ultrasound imaging, and soon focused ultrasound neuromodulation. Participants are people with a sonolucent cranial implant, usually placed after surgery for traumatic brain injury, stroke, or a tumor. The studies are longitudinal: the same participant returns over months, first in the lab or clinic and eventually at home. We work in partnership with hospitals and academic centers, here and in the UK.

The program needs to grow, and much of the infrastructure for that doesn't exist yet. 

Part of the job is conventional clinical operations: IRB submissions and amendments, protocol preparation, site readiness, participant scheduling and support, safety monitoring, documentation, and training systems. You'd own all of it. We're small, so for now that means doing the work as much as overseeing it.

The second part is harder to specify and a bigger challenge. Our program will depend on the quality and scale of our relationships with clinicians and hospital departments. Building and maintaining those partnerships requires a real understanding of where our interests align. This would be yours to own.

You'd also help grow our studies beyond the clinic. At-home longitudinal neuromodulation is where this program is headed, and we don’t yet know what that requires. Some of the answers are technical, and some will come from spending time with participants and seeing what their lives are like at home.

What You’ll Do

Build the clinical program:

Partner with scientific leadership on clinical strategy: which sites and partnerships and where our incentives align

Develop and own a recruitment program from a small and geographically scattered participant pool

Qualify and onboard clinical partners

Help design what at-home studies will require, from participant experience through logistics and safety

Run the studies:

Lead start-up for internal and external studies

Own our IRB submissions and ongoing interactions

Manage participant scheduling, visits, follow-up, payments, and travel

Coordinate device deployment, equipment readiness, and study-specific technical support; you don't need to run experiments, but you should be able to troubleshoot them

Establish and maintain TMF, document control, clinical SOPs, and the personnel training program

Own adverse event tracking and reporting

Where you start will depend on your strengths and on what the program needs most. This won't stay one person's job as Arbor grows.

Who We’re Looking For

The successful candidate will have:

Substantial experience in human clinical research operations

Enough scientific training to engage substantively with clinicians and researchers and to step in and help run a study when we need it. Advanced training, ideally a PhD in a relevant field, is the most common route, but not the only one

The written and spoken communication skills to explain the research to participants and collaborators and to produce final drafts of key documents

The organizational and interpersonal skills to keep everyone moving in the same direction, often with no established process to follow

The ambition to build clinical infrastructure, not just run it

Directness without friction – you say what you think, ask when you don't know, and aren't looking to compete with your colleagues

Nice to have: background in neuroscience, neuroimaging, neuromodulation; work with hospitals, academic medical centers, or external clinical research partners; early-stage medical device or biotech experience; familiarity with ICH-GCP, ISO 14155, and FDA medical device requirements; experience with QMS, CTMS, or eTMF systems; AE/SAE reporting, monitoring, CAPAs, and audit readiness.