Clinical Operations Manager — Clinical Validation & Medical AI Studies

Our teams are developing breakthrough 3D multimodal foundation models and agentic medical AI systems designed to assist radiologists and clinicians across diverse workflows.
Your role is to lead the clinical validation studies that ensure these systems meet the highest standards of accuracy, safety, reliability, and clinical utility.

You will design, coordinate, and oversee retrospective and prospective clinical studies in collaboration with hospital partners, radiology groups, CROs, and internal research teams. Your work directly determines how our AI systems are trusted and adopted in clinical environments.

This is a pivotal role for someone who wants to combine clinical research rigor with frontier AI innovation.

• Develop, manage, and execute clinical validation protocols for 3D AI models and agentic medical systems.
• Lead retrospective, prospective, observational, and workflow-integration studies.
• Define clinical endpoints, evaluation criteria, inclusion/exclusion criteria, and ground truth generation methodologies.
• Coordinate IRB/IEC submissions, ethics approvals, and regulatory documentation.

• Identify, onboard, and manage clinical sites (hospitals, imaging centers, academic partners).
• Train site investigators, radiologists, and clinical staff in study procedures and data collection workflows.
• Maintain strong, trust-based relationships with clinicians and site coordinators.

• Oversee secure, compliant collection of medical imaging and text data (DICOM, reports, annotations).
• Ensure adherence to local and international clinical research regulations (ICMR, GCP, HIPAA-equivalent, MDR).
• Lead safety monitoring, data audits, and deviation management.

• Work closely with AI researchers, product managers, and regulatory specialists to align study designs with model capabilities and regulatory requirements.
• Provide clinical insights that shape model evaluation metrics, dataset selection, and product features.
• Manage communication of progress, risks, and results across engineering, research, and executive teams.

• Create comprehensive study reports for regulatory filings, publications, whitepapers, and clinical partner communication.
• Lead statistical analysis planning and coordinate with biostatisticians for rigorous interpretation of study results.
• Present clinical findings internally and externally at conferences, workshops, and partner meetings.

• You define the clinical evidence strategy for new AI systems capable of multimodal 3D reasoning.
• Your work directly affects regulatory approval, hospital adoption, and clinician trust.
• You operate at the cutting edge of medical AI validation, where standard frameworks are still emerging.
• You collaborate with top radiologists, hospitals, and AI researchers to shape the future of clinical AI.

• 5+ years experience in clinical operations, clinical research management, or medical device trials.
• Strong understanding of GCP, clinical study protocols, regulatory compliance, and ethics board processes.
• Experience managing imaging-centric or medical device studies (radiology preferred).
• Ability to collaborate with clinicians, CROs, investigators, and regulatory bodies.
• Excellent project management skills: planning, documentation, risk management, and execution.
• Strong communication, stakeholder alignment, and problem-solving abilities.
• Passion for improving patient outcomes using next-generation AI technologies.

• Experience with AI/ML-based medical device evaluations (SaMD).
• Background in radiology, clinical imaging workflows, or 3D data interpretation.
• Familiarity with FDA/EMA/ICMR/NDHM guidelines for AI medical systems.
• Prior experience generating or managing ground truth annotation workflows.
• Exposure to biostatistics, ROC/AUC analysis, reader studies, and multi-reader multi-case (MRMC) study design.