Primary Function of Position

The purpose of the Director, Clinical Affairs is to oversee and manage all aspects of clinical operations for Pre and Post Market studies and to guide, develop, and execute long-range clinical trial strategies for Investigational Device Exemption (IDE) and Post Market studies in the US and provide strategic guidance for global clinical evidence strategies for Intuitive’s Clinical programs.

As a key cross-functional constituent, this employee will work in a global matrix with teams across R&D, New and sustaining product development, Clinical Development engineering, Regulatory Affairs, Regulatory Compliance, Post-Market Surveillance, Global Access Value Economics (GAVE), Global Public Affairs (GPA), and Medical officers to optimize clinical evidence strategies to meet business objectives.

This position will be responsible for developing and coordinating various strategic and tactical clinical evidence-generation activities to support regulatory clearance for new products and new indications. For clinical operations, this position will be responsible for the planning, implementation, execution, and management of clinical studies by overseeing day-to-day operations and directly managing and working with outside Clinical Research Organizations (CROs), clinical sites and their teams, and third-party vendors. You will thrive in a fast-paced, innovative environment, while remaining flexible, proactive, resourceful, and efficient.

Essential Job Duties (Role and Responsibilities)

• Play a lead role in the development of the company's clinical and scientific strategies for clinical studies for pre-market submission in the US IDE studies and Post-Market Studies.
• Responsible for providing strategic guidance to global clinical evidence strategy for selected clinical programs.
• Direct leadership and management of clinical research infrastructure, including but not limited to development of clinical research protocols, case report forms, informed consent forms, management of trial master files, study-site assistance with IRB process and documentation preparation, study monitoring and investigator requirements, recruitment, and contracts preparation in conjunction with the clinical research team.
• Direct leadership and management of clinical research workflows, including data collection, data management, data analysis, interpretation of clinical data and clinical study reports, in conjunction with the clinical research team.
• Directly or indirectly supervise clinical research staff, including consultants and third parties. Builds strong, trusting, and cooperative relationships with others across multiple projects.
• Direct the operational aspects of company sponsored (and related) clinical research and regularly reports on progress and status including initiating and leading team meetings.
• Direct the development of clinical research strategy, timelines, milestones, project plans/deliverables, budget and resource allocations.
• Oversee the timely capture, reporting, and evaluation of adverse events
• Responsible for cross-functional collaboration with various key functions within the organization to shape the external environment through interactions with notified bodies, regulatory agencies, and external working groups.
• Drive the development and implementation of pre-market submission and Post-Market clinical research strategies to meet business goals and objectives. Responsible for setting effective goals that are meaningful to the department and impactful to the organization.
• Ensure compliance with corporate (e.g., SOP's) and regulatory requirements (e.g., GCP and US and OUS guidelines)
• Provides solutions and efficiencies for departmental process improvements and standard operating procedures.
• As a functional manager, this role is responsible for effectively coaching and guiding team members in their internal/external communication and support direct reports in consistently achieving their goals and objectives while reinforcing a culture of inclusion and diversity.
• Effectively distills complexity and provides clear and actionable direction and information.

Required Skills and Experience

• Strategies for IDE and other premarket/post-market studies is required.
• Proven track record of leadership by example and developing high-performing teams.
• Excellent ability to interact with physicians and other professionals inside and outside the company.
• Entrepreneurial, collaborative, strategic thinker with excellent project management skills and ability to prioritize and plan.
• Prior experience in medical robotics, surgical devices, and operating rooms is highly preferred.
• Results-driven attitude & a resolve to win; must be self-directed and able to work with minimal supervision.
• Excellent interpersonal skills with an emphasis on leadership, relationship development, and influence management.
• Superior verbal/written communication and presentation skills, team building, and interpersonal skills to work across multiple constituents.
• Must be able to travel up to 30-40%, including frequent travel to HQ in Sunnyvale

Required Education and Training

• Advanced degrees such as M.D, MS or PhD in the scientific/bioengineering field with 8-12 years of experience in clinical affairs/research project management is preferred, and at least 3-5 years of management experience.
• Possess knowledge of Good Clinical Practice and 21 CFR medical device regulations, ISO 14155, Med Dev/MDR regulations, and other international regulations.
• Strong understanding and background in clinical trials, study design, and formal ICH/GCP knowledge and training.

Working Conditions:

None

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.