Clinical Development Lead

Intuitive•Sunnyvale, CA

10d•Hybrid

About The Position

The Clinical Development Lead will oversee the planning, design, execution, and analysis of clinical studies to gather data and demonstrate the safety, efficacy, and clinical utility of novel robotics, imaging, and AI-based products. This role combines deep expertise in clinical study design and analytics with hands-on oversight of trial delivery and cross-functional teamwork. Clinical study operations and working directly with sites will be a significant element of this role, including travel in the US to clinical sites and to travel to international sites as needed. Ability to work in San Carlos, CA or travel frequently to San Carlos, CA is required.

Requirements

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
Strong knowledge of clinical validation approaches for medical devices and familiarity with FDA, CE Mark, and other global regulatory requirements
Excellent project management, analytical, and leadership skills
Advanced degree (PhD, MD, Masters, or equivalent) in biomedical sciences, clinical research, pathology, or related field

Nice To Haves

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

Responsibilities

Oversee the operational planning and execution of clinical trials, including site discovery and initiation, patient/sample acquisition, monitoring, and close-out
Negotiate and manage study timelines, budgets, and vendor/CRO relationships to deliver studies on schedule, within scope, and with high data integrity
Direct day-to-day activities of the clinical team, ensuring adherence to protocols, data integrity, and compliance with GCP and regulatory standards.
Develop and optimize SOPs for site management, data collection, and trial monitoring
Identify, assess, and mitigate scientific and operational risks throughout the study lifecycle
Design scientifically robust clinical studies to demonstrate safety, effectiveness, and clinical utility
Develop endpoints, 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, publications, and product claims