Sr. Director, Clinical Affairs - Endoluminal

Intuitive•Sunnyvale, CA

About The Position

The Senior Director, Clinical Affairs for Endoluminal guides, develops, and executes long-range clinical evidence strategies for Intuitive’s Endoluminal Business Unit. This includes first-human-use research, regulatory studies, and post-market evidence generation, as well as strategic oversight of global clinical evidence programs. The role coordinates evidence-generation and dissemination activities that support regulatory clearance for new products and indications and works across a global matrix of clinical, engineering, product development, regulatory, surveillance, market access, and public affairs teams. The position develops integrated clinical evidence plans aligned with business priorities, regulatory requirements, and reimbursement submissions. It leads clinical research strategy, manages clinical trial budgets, and provides direction to the broader Clinical Affairs team. As a functional manager, the role coaches direct reports, supports their achievement of goals, and reinforces an inclusive and diverse culture. The role also serves as a subject matter expert on clinical literature and outcomes for Endoluminal procedures, contributes to market intelligence, and reviews or approves clinical investigation plans, study reports, and post-market clinical follow-up plans. Travel of up to 30–40%, including international travel, may be required. Intuitive and/or its customers may require proof of vaccination against certain diseases, including COVID-19, depending on the role.

Requirements

Advanced degree such as an M.D., M.S., or Ph.D. in a scientific or bioengineering field, with 8–12 years of experience in clinical affairs or research project management preferred; relevant experience with a technical degree and/or master’s degree may qualify.
At least 3–5 years of management experience.
Experience assisting with scientific strategy development for IDE, pre-market (such as first-human-use), and/or post-market evidence generation.
Knowledge of Good Clinical Practice, 21 CFR medical device regulations, ISO 14155, MedDev/MDR regulations, and other international regulations.
Solid knowledge and background in clinical trials and study design, and formal ICH/GCP knowledge and training.
Demonstrated leadership by example and experience developing high-performing teams.
Ability to interact effectively with physicians and other professionals inside and outside the company.
Strategic thinking, project management skills, prioritization, planning, and ability to work cooperatively.
Self-directed, results-driven approach and ability to work with minimal supervision.
Strong relationship-building, employee-development, leadership, and influence-management skills.
Excellent verbal and written communication and presentation skills, teambuilding ability, and relational skills for working across multiple constituents.
Ability to travel up to 30–40%, including international travel as needed.

Nice To Haves

Experience in medical robotics, surgical devices, flexible catheter devices, or operating-room settings is highly preferred.
Advanced degree and 8–12 years of clinical affairs or research project management experience are preferred.

Responsibilities

Lead development of clinical and scientific strategies, including studies for new product development, first human use, IDE studies, post-market evidence generation, and emerging markets.
Develop and execute clinical study plans that comply with applicable regulatory requirements, including MDR, GCP, and ISO 14155.
Provide strategic guidance for global Endoluminal clinical evidence planning in partnership with business-unit stakeholders, including medical officers, regulatory teams, and regional organizations.
Coordinate integrated evidence planning and execution to support reimbursement submissions.
Build cross-functional relationships and partnerships with regulators, professional societies, key opinion leaders, and customers.
Translate strategic, corporate, and technical content into clear evidence roadmaps that engage multiple functions.
Create key performance indicators and three-year evidence plans to support Endoluminal Business Unit strategic initiatives.
Drive clinical research strategies aligned with business goals and priorities, and establish meaningful departmental goals.
Manage year-over-year clinical trial program budgets.
Provide leadership and direction to the broader Clinical Affairs team and address current and future opportunities and issues.
Ensure compliance with corporate procedures and regulatory requirements, including GCP and U.S. and non-U.S. guidelines.
Develop solutions and efficiencies for departmental processes and standard operating procedures.
Serve as a subject matter expert on literature and clinical outcomes for procedures related to Endoluminal technologies.
Contribute to market intelligence on clinical outcomes for Intuitive and competitor technologies.
Contribute to, review, and approve clinical documents and plans, including Clinical Investigation Plans, Clinical Study Reports, and Post-Market Clinical Follow-up plans.
Coach and guide team members in internal and external communications and support their achievement of goals and targets while reinforcing inclusion and diversity.
Travel up to 30–40%, including internationally as needed.