Company Description
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.
Job Description
Primary Function of Position
As a Senior Manager of Clinical Affairs, this role is responsible for contributing to clinical strategies and overseeing study execution for emerging technologies across various specialties. Clinical trials in this portfolio may be both in the US and global and include first-human-use and pivotal clinical trials targeted for regulatory submission. This role will oversee and manages clinical protocols and other key study documents in support of regulatory submissions; manage clinical publications and evidence dissemination strategy, oversee manage communications with clinical trial sites, CROs, KOLs and medical societies; grow, develop and manage team to interface and support all clinical requirements of the company with the applicable guidelines and regulations; foresee challenges and develops critical concepts and methodologies to overcome those. As a functional manager, this role will also lead a team of clinical operations personnel, such as clinical study managers and clinical research associates and play a key role in their development.
As a key cross-functional constituent, this employee will work closely with functions across the organization – Regulatory Affairs, R&D, Program Management Office (PMO), Clinical Research Engineering (CRE), Clinical Research Managers, Global Access Value Economics (GAVE), Global Public Affairs (GPA), Regulatory Compliance, Training, Legal, and commercial functions to optimize clinical study strategies to meet business objectives.
Roles and 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
Qualifications
Skill/Job Requirements
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
Previous experience supporting internal and external audit on clinical studies is preferred
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%
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.
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.
Base Compensation Range Region 1: $185,600 USD - $278,400 USD
Base Compensation Range Region 2: $157,800 USD - $236,600 USD
Shift: Day
Workplace Type: Set Schedule - This job will be onsite weekly, the percentage of onsite work will be defined by the leader.
