Clinical Operations Lead

Protocol Labs, Inc.; San Francisco (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Arbor Neuroscience is a nonprofit research organization pursuing neuromodulation through functional ultrasound imaging and later at-home longitudinal studies. The role focuses on building and scaling the clinical program, managing IRB submissions, and developing partnerships with hospitals and academic centers in the US and abroad.

You'll lead startup efforts for studies, design at-home study requirements, and recruit clinical partners.

Qualifications

• Substantial experience in human clinical research operations.
• Advanced scientific training; PhD is common but not mandatory.
• Excellent written and spoken communication with participants and collaborators.
• Strong organizational and interpersonal skills to coordinate teams.
• Ambition to build clinical infrastructure, not just run it.
• Directness to say what you think and ask questions when in doubt.

Responsibilities

• Partner with scientific leadership on clinical strategy and partnerships.
• Develop and own recruitment program from a small, geographically scattered pool.
• Qualify and onboard clinical partners.
• Design what at-home studies require, from participant experience to logistics and safety.
• 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 tech support; troubleshoot when needed.
• Establish and maintain TMF, document control, clinical SOPs, and staff training.
• Own adverse event tracking and reporting.

Skills

Clinical research operations

Scientific training

Communication skills

Organizational skills

Interpersonal skills

Infrastructure building

Direct communication

Education

PhD in a relevant field

Job description

About Arbor Neuroscience

(formerly Forest Neurotech)

Arbor is a nonprofit research organization working on one of the hardest open problems in clinical neuroscience: how to change brain circuits by design.

Millions of people with depression, chronic pain, and other brain disorders have no treatment that works. Modulating activity in the brain circuits underlying their symptoms - with electrical stimulation, focused ultrasound, or magnetic stimulation - can work spectacularly well. But it doesn't work reliably, and we can't predict who it will help.

That's what Arbor aims to fix. The starting point is a new class of experiment: intervene, measure how the circuit responds, track the symptom, and repeat in the same individual over months. We're building the necessary experimental platform. It currently includes the Forest 1 ultrasound system, which works like a wearable functional MRI, but with higher resolution. The system images activity across large brain volumes, including deep brain structures, and will soon stimulate as well. We are also adding electrode-based interfaces in animal studies. From these data, we'll build models to make neuromodulation predictable.

Arbor is a Focused Research Organization within the Convergent Research family, and the new name for Forest Neurotech. We're a mission-focused nonprofit, doing multidisciplinary translational work that doesn't fit in a lab or on a company roadmap. We have the funding to run the first phase, and we're a small team - the people we hire now will shape what Arbor becomes.

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.