Intuitive · 6 days ago
Senior Manager, Clinical Affairs
Sunnyvale, CA
Full-time
Onsite
Senior Level, Lead/Staff
$160K/yr - $241K/yr
12+ years expIntuitive is a pioneer and market leader in robotic-assisted surgery, committed to advancing minimally invasive care. The Senior Manager of Clinical Affairs will contribute to clinical strategies and oversee study execution for emerging technologies, managing clinical protocols and communications with various stakeholders.
Health CareManufacturingMedical Device
Responsibilities
Play a key role in the development of company’s strategy for clinical studies to meet business goals and objectives. Collaborate with internal stakeholders and KOLs to develop and review study concepts, protocol and study outlines and subsequently driving identified initiatives
Acting as a key strategic partner to Regulatory Affairs to support regulatory approval of new products and contribute to clinical sections of regulatory submissions
Responsible for managing resource and study budget to ensure clinical studies are conduced on schedule and within budget while ensuring high quality and compliance
Build strong and sustaining relationship with investigational sites and investigators for ongoing and future studies
Work closely with data management to provide guidance on development of case report form (CRF), data cleaning to ensure collection of high quality data
Work closely with Biostats in study design, developing statistical analysis plan (SAP), analysis, interpretation and synthesis in order to develop Clinical Study Report and /or support development of scientific publications
Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US FDA regulations and guidelines) and responsible for ongoing review of departmental procedures and process improvement initiatives
Responsible for setting up effective goals that are meaningful to the department and impactful to the organizations
Provide functional manager leadership to direct reports and provide ongoing guidance for the assigned team members in their internal/external communication and support direct reports in consistently achieving their goals and objectives
Sets and hold individual and team accountable for high standard of competencies and overall performance
Effectively distills complexity and provides clear and actionable direction and information, help team prioritize, solve complex problems that enable the team to make significant progress
Develop talents, build a highly capable and effective team of clinical study managers (CSM) and clinical research associates (CRA) to efficiently manage clinical studies
Qualification
Required
Minimum Education: Bachelor's or Master's degree in scientific field/MD/ PhD with 12+ years of professional experience and at least 3-5 years of supervisory experience is preferred
Minimum of 5 years of experience independently managing clinical studies through different study phases (pre-IDE, IDE submission, site selection and activation, study execution, data analysis and study report, and closeout)
Excellent clinical operation and project management skills, with strong experience collaborating or leading a cross-functional team
Proven track record of strong cross-functional and key opinion leader management
Strong experience with clinical study resource and budget management
Strong experience supporting development of scientific and regulatory strategy for clinical studies
Strong experience in developing study protocol and other study documents, conducting literature review, writing clinical section for regulatory submission
Strong knowledge of 21 CFR part 812 , Good Clinical Practice, ISO14155 and other regulations/guidelines
Basic understanding of statistics, statistical methods, and design of experiment
Excellent ability to interact with physicians and other professionals inside and outside the company
Comfortable in a hospital environment, with experience working with nurses and surgeons; existing or previous experience/familiarity with surgery/surgical technology is preferred
Strong communication, presentation and interpersonal skills with high attention to detail and organization
Results-driven attitude and strong problem solving skills, consistently shows dedication or strong work-ethic to help meet aggressive timelines or multiple projects when necessary
Must be able to travel up to 30-40%
Preferred
Previous experience supporting internal and external audit on clinical studies is preferred
Comfortable in a hospital environment, with experience working with nurses and surgeons; existing or previous experience/familiarity with surgery/surgical technology is preferred
Company
Intuitive
Intuitive designs and manufactures robotic-assisted surgical systems.
10001+ employees
H1B Sponsorship
Intuitive has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (339)
2024 (238)
2023 (181)
2022 (285)
2021 (145)
2020 (138)
Funding
Current Stage
Public CompanyTotal Funding
$5MKey Investors
St. Cloud Capital
2003-04-30Post Ipo Equity
2000-06-23IPO
1996-01-01Seed· $5M
Leadership Team
Craig Child
Sr. Vice President, Human Resources
Gillian Duncan
Senior Vice President, Professional Education & Program Services - Worldwide
Recent News
2025-12-11
2025-11-14
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