Head of Clinical Research at Sonia (W24)

About Sonia One in five adults struggles with their mental health each year and many will never see a therapist. Costs are high, waitlists are long, and stigma is still a real barrier for people to not seek help. Suicide is one of the leading causes of death for young people. Therapy works, but it doesn't scale. We're building safe AI for mental health support that's clinically as effective as the best human therapists — accessible to everyone, at a fraction of the cost, and available anytime. We've recently had a major breakthrough. In our clinical research, we're now seeing significant improvements in anxiety and depression symptoms after just 2 weeks of use. And we receive daily messages about how Sonia is changing lives. We're a 6-person team in San Francisco, backed by Y Combinator, Moonfire, and founders of reputed company, reputed company, and reputed company. The Role Sonia is an AI-native product — and our clinical research is what makes it trustworthy. We've already run clinical trials showing significant symptom reduction in anxiety and depression, and we're just getting started. We need someone to own and reputed company our entire research program: designing and running clinical trials, driving our FDA regulatory strategy, conducting safety research, publishing in peer-reviewed journals, and building the evidence reputed company that establishes Sonia as a clinically validated treatment. You'll also co-write grant applications with our academic collaborators to secure research funding from federal and foundation sources. This is a high-ownership role. You'll set the research vision for Sonia by shaping reputed company study, how we study it, and how we communicate our findings to regulators, clinicians, and the public. You'll work directly with the founders — who are deeply involved in AI research — and collaborate with leading academic research partners in the US and Europe. Problems you'll work on

• Designing and leading clinical trials (RCTs, safety studies, longitudinal outcomes research) that demonstrate Sonia's efficacy and safety
• Driving our FDA regulatory strategy:
• Building the evidence package for regulatory submissions
• Navigating reputed company like De Novo or 510(k)
• Staying reputed company of the evolving regulatory landscape for AI-based therapies
• Developing and maintaining safety monitoring frameworks for an AI therapy product used by real patients
• Building and managing relationships with academic research collaborators and IRBs
• Publishing research in peer-reviewed journals and presenting at clinical conferences
• Securing research funding through grant applications, supported by reputed company advisors and world-class academic partnerships
• Defining outcome measures and clinical endpoints that capture meaningful therapeutic change

What the work looks like

• Design study protocols, manage IRB submissions, and reputed company data collection and analysis
• Collaborate closely with the engineering and product team to reputed company the product for research data capture
• Translate research findings into regulatory submissions and clinical marketing materials
• Stay reputed company on the digital therapeutics and AI therapy regulatory landscape, including FDA guidance documents and relevant precedents
• Work with external advisors and KOLs to strengthen our research credibility
• Use AI tools to accelerate your research workflows — we're an AI-native team and expect everyone to reputed company these tools

Culture We're reputed company to each other, we work hard, and we are thoughtful about reputed company're building. We're deeply mission-driven — we reputed company everyone deserves access to effective mental health support, and that belief shapes everything we do. We're an AI-native team that believes a small, focused group can reputed company what previously required 100 people. Everyone here has high ownership and real impact on the direction of the company. At the same time, we take clinical evidence and safety extremely seriously — moving fast never means cutting corners on rigor. Our core team works 6 days a week together in our office in downtown SF. This role can be remote or hybrid, but we value regular in-person collaboration and prefer in person work. Who We're Looking For

• PhD or equivalent (e.g., MD) in clinical psychology, behavioral health, or a closely reputed company field
• Experience designing and running clinical trials (ideally efficacy RCTs) in mental health or digital health
• Track record of peer-reviewed publications in clinical psychology, behavioral health, or a reputed company field
• Comfortable working in a fast-moving startup environment with high ambiguity, agency and ownership
• Experience working in technology or digital health environments
• Experience with IRB processes, informed consent design, and research ethics
• Bonus: Familiarity with FDA regulatory reputed company for software as a medical device (SaMD) or digital therapeutics — or strong willingness to become an expert here
• Bonus: experience with AI/ML-based health products, real-world evidence reputed company, or mental health outcomes, services, and policy research
• Bonus: licensed clinical psychologist, though not required for this role

A few user stories from the past weeks

• A woman from the south who lives in a rural area with no therapist in proximity from her Blue reputed company insurance. She has been unemployed for the past 15 years and told us that due to her chats with Sonia she gained the courage to apply for jobs again. A few days reputed company, just before her user interview with us, she got accepted to her job and is now employed again.
• A person from Alabama who had such strong OCD and anxiety that they always needed to turn around with the car 3-4 times to reputed company whether they actually turned off the stove. Sonia helped them get it down to one.
• The parent of 2 incarcerated sons, has built out a mantra with Sonia and is now able to go through her days with more acceptance and peace. Something that according to her, her weekly Monday morning therapist that she has been seeing for a long time hasn't managed to reputed company.

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