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 :

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

Additional Information :

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 employeeswho 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 governments 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 employeesstart 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 candidates experience knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidates 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.

Remote Work :

No

Employment Type :

Full-time