Intuitive
healthcare
ClinicalDevelopmentLead
“Clinical Development Lead at Intuitive. Skills: clinical study design, clinical study operations, AI-based products, robotics, imaging. Oversee the planning, design, execution, and analysis of clinical studies. Gather data and demonstrate the safety, efficacy, and clinical utility of novel robotics, imaging, and AI-based products”
What You'll Achieve.
demonstrate the safety, efficacy, and clinical utility of novel robotics, imaging, and AI-based products; deliver studies on schedule, within scope, and with high data integrity; improve outcomes around the world; make surgery smarter, safer, and more human
Industry & Context.
analytical skills; Identify, assess, and mitigate scientific and operational risks
travel in the US to clinical sites, travel to international sites as needed, Ability to work in San Carlos, CA or travel frequently to San Carlos, CA is required, proof of vaccination against certain diseases including COVID-19 may be required, subject to U.S. export controls
What They're Looking For.
Must Have
3+ years of hands-on clinical study design and operations experience in medical devices or diagnostics, Proven track record in managing multi-site trials and working with CROs, knowledge of clinical validation approaches for medical devices, familiarity with FDA, CE Mark, and other global regulatory requirements, Excellent project management, analytical, and leadership skills
Nice to Have
Prior experience in medical imaging and digital pathology, Prior experience with AI-enabled medical devices, Experience with reader studies for medical devices, Experience with prospective studies for medical devices in the OR or procedural settings
What You'll Do.
and analysis of clinical studies
Gather data and demonstrate the safety
and clinical utility of novel robotics
and AI-based products
Oversee the operational planning and execution of clinical trials
including site discovery and initiation
patient/sample acquisition
Negotiate and manage study timelines
and vendor/CRO relationships
Direct day-to-day activities of the clinical team
ensuring adherence to protocols
and compliance with GCP and regulatory standards
Develop and optimize SOPs for site management
and mitigate scientific and operational risks throughout the study lifecycle
Design scientifically robust clinical studies to demonstrate safety
inclusion/exclusion criteria
and statistical analysis plans
Collaborate with physicians and scientific advisors to ensure clinical relevance and compliance with scientific best practices
Interpret clinical data and drive the generation of evidence for research and development
regulatory submissions
How You'll Work.
Team & Collaboration
cross-functional teamwork; Collaborate with physicians and scientific advisors
Process & Methodology
Negotiate and manage study timelines, budgets, and vendor/CRO relationships, Excellent project management skills
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