Clinical Development Lead

About This Opportunity:

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.

Clinical Operations & Execution

• 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

Clinical Science & Study Design

• 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

 

Qualifications:

• 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

• Education: Advanced degree (PhD, MD, Masters, or equivalent) in biomedical sciences, clinical research, pathology, or related field

Preferred Qualifications:

• 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

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.

We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.

If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here.

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

Mandatory Notices

U.S. Export Controls Disclaimer:  In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees
who are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).  

For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s
start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes. 

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate’s experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate’s qualifications, consistent with applicable law.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.