Manager of Clinical Research

Responsibilities

• Own end-to-end execution of AQMed's clinical study portfolio, from feasibility through pivotal studies across the US, Europe, and Asia.
• Develop and maintain clinical study plans, protocols, budgets, agreements, and timelines.
• Lead site identification, qualification, initiation, monitoring, and close-out for multi-center, multi-geography studies.
• Serve as the primary operational owner for all IRB/Ethics Committee submissions, amendments, and reporting.
• Select, onboard, and manage external clinical consultants and CRO partners to ensure high standards of quality and speed.
• Build and sustain trusted relationships with clinical investigators, coordinators, and hospital administration.
• Collaborate cross-functionally with Product, Data Science, and Engineering to ensure clinically meaningful study designs.
• Partner with regulatory and quality teams on 510(k)/De Novo submissions and QMS compliance.

Requirements

• 10+ years of clinical research experience in medical devices or diagnostics.
• Demonstrated success leading multi-center clinical trials across multiple geographies.
• Strong working knowledge of 21 CFR Parts 812/820, ISO 14155, and EU MDR.
• Experience as the primary clinical lead on studies supporting regulatory submissions (510(k), De Novo, or CE Mark).
• Proven ability to manage CROs and external clinical consultants with precision.
• Exceptional organizational and program management skills.

Preferred Qualifications

• Experience in cardiology, electrophysiology, or cardiovascular diagnostics.
• Familiarity with SaMD regulatory pathways and AI/ML-based medical device submissions.
• Prior experience as a founding or first clinical hire at a startup or early-stage medtech company.
• An AI-forward mindset with curiosity regarding how AI tools can accelerate clinical research workflows.
• Active network of clinical investigators in cardiology or emergency medicine.
• Advanced degree in life sciences, clinical research, or nursing.

Benefits

• Competitive base salary, performance-based incentives, and equity participation.
• Comprehensive medical, dental, and vision coverage with generous employer contributions.
• Retirement savings with company matching and paid parental leave.
• Flexible paid time off and company-wide seasonal breaks.

About the Company

SandboxAQ is a high-growth company delivering AI solutions that address some of the world's greatest challenges. Emerging from Alphabet Inc., we use Large Quantitative Models (LQMs) to power advances in life sciences, cybersecurity, and more. We foster a collaborative environment where experts in AI, physics, and medicine work together to tackle epic global challenges.