Manager of Clinical Research, AQMed

About the role

AQMed is developing a next-generation, non-invasive cardiac diagnostic platform designed to revolutionize how heart health is assessed. The team operates at the intersection of regulated medical device development and fast-paced startup innovation, with a strong emphasis on quality, scientific rigor, and patient safety. We are seeking a Manager of Clinical Research who will own and accelerate AQMed's clinical program. You will inherit a meaningful foundation - established processes and early clinical work already underway - and take it to the next level. You will drive execution of a multi-geography clinical program from feasibility to pivotal studies, working alongside external support (e.g. consultants, CRO) while serving as the internal authority and integrating point for all things clinical. We are looking for a resourceful, deeply experienced clinical operator who thrives in ambiguity and moves with urgency. You bring proven multi-center trial leadership, global site management experience, and the judgment to make smart and data-driven decisions. You are equally comfortable in a site coordinator meeting, an FDA pre-submission discussion, or a cross-functional planning sprint - and you do whatever it takes to keep the program moving. Notably, you are AI-forward: curious about how AI tools can accelerate clinical research workflows, and eager to apply them to improve speed, quality, and efficiency across the program.

Responsibilities

• Clinical Program Leadership
• Own end-to-end execution of AQMed's clinical study portfolio, from feasibility through pivotal and across the US, Europe, and Asia.
• Develop and maintain clinical study plans, protocols, budgets, agreements, timelines; proactively identify and resolve threats to enrollment, data quality, and regulatory timelines.
• Lead site identification, qualification, initiation, monitoring, and close-out across multi-center, multi-geography studies.
• Serve as the primary operational owner of all IRB/ Ethics Committee submissions, amendments, and ongoing reporting requirements.
• Select, onboard, and manage external clinical consultants and/or CRO partners; hold them to high standards of quality, speed, and accountability.
• Define clear scopes of work, success metrics, and escalation paths for all external clinical resources.
• Site & Investigator Management
• Build and sustain trusted relationships with clinical investigators, coordinators, and hospital administration at each study site.
• Drive enrollment with creativity and urgency; designing site-specific strategies, troubleshooting bottlenecks, and escalating risks early.
• Conduct or coordinate site visits (in-person and remote) and ensure protocol adherence, data integrity, and GCP compliance at all sites.
• Cross-Functional Partnership
• Collaborate with Product, Data Science, and Engineering to ensure study designs generate data that is both clinically meaningful, actionable and useful.
• Partner with regulatory & quality on clinical inputs for 510(k)/ De Novo submissions, FDA interactions, and QMS compliance (21 CFR Parts 812/820, ISO 14155, EU MDR guidelines).
• Partner with the GM and VP of Commercial Strategy on evidence strategy - which studies to run, which endpoints matter, and how clinical data supports the indication roadmap and reimbursement narrative.
• Represent AQMed's clinical program credibly with investigators, hospital partners, SAB members.
• Essential Skills & Experience
• 10+ years of clinical research experience in medical devices or diagnostics, with hands-on execution responsibility across the full study lifecycle.
• Demonstrated success leading multi-center clinical trials across multiple geographies, including site management, IRB/EC submissions, and regulatory coordination. Proven track record across multiple study types: feasibility studies, pivotal studies both US & OUS.
• Strong working knowledge of 21 CFR Parts 812/820, ISO 14155, EU MDR.
• Exceptional organizational and pr

Benefits

Additional Information

About SandboxAQ SandboxAQ is a high-growth company delivering AI solutions that address some of the world's greatest challenges. The company's Large Quantitative Models (LQMs) power advances in life sciences, financial services, navigation, cybersecurity, and other sectors. We are a global team that is tech-focused and includes experts in AI, chemistry, cybersecurity, physics, mathematics, medicine, engineering, and other specialties. The company emerged from Alphabet Inc. as an independent, growth capital-backed company in 2022, funded by leading investors and supported by a braintrust of industry leaders. At SandboxAQ, we've cultivated an environment that encourages creativity, collaboration, and impact. By investing deeply in our people, we're building a thriving, global workforce poised to tackle the world's epic challenges. Join us to advance your career in pursuit of an inspiring mission, in a community of like-minded people who value entrepreneurialism, ownership, and transformative impact.

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