Sr. Director, Clinical Affairs - Endoluminal

Intuitive•Sunnyvale, CA

4d•$231,200 - $408,000•Onsite

About The Position

The Senior Director, Clinical Affairs—Endoluminal guides, develops, and executes long-range clinical evidence strategies for Intuitive’s Endoluminal Business Unit. These strategies include first-human-use studies, regulatory studies, and post-market evidence generation, as well as strategic oversight of global clinical evidence activities. The role coordinates strategic and tactical evidence generation and dissemination to support regulatory clearance for new products and indications. Working in a global, cross-functional matrix, the Senior Director partners with Endoluminal Medical Officers, R&D, product development, Clinical Development Engineering, Regulatory Affairs and Compliance, Post Market Surveillance, Global Access Value Economics, and Global Public Affairs. The position develops integrated evidence plans aligned with business priorities, regulatory requirements, and reimbursement submissions. As a functional manager, the role also provides leadership, coaching, and direction to team members.

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; at least 3–5 years of management experience. Relevant experience combined with a technical degree and/or master’s degree may qualify.
Experience assisting with development of scientific strategies 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.
Strong knowledge and background in clinical trials, 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, entrepreneurial, and cooperative approach, with strong project-management skills and the ability to prioritize and plan.
Results-driven and self-directed, with the ability to work with minimal supervision.
Strong relationship-building, leadership, employee-development, and influence-management skills.
Excellent verbal, written, and presentation skills, with the ability to build teams and work across multiple stakeholder groups.
Ability to travel up to 30–40%, including internationally as needed.

Nice To Haves

Experience in medical robotics, surgical devices, flexible catheter devices, or operating-room settings.

Responsibilities

Develop the company’s clinical and scientific strategies, including studies for new product development, first human use, IDE studies, post-market evidence generation, and emerging markets for Endoluminal technology.
Develop and execute clinical study plans that comply with applicable regulatory requirements, including MDR, GCP, and ISO 14155.
Provide strategic guidance for global clinical evidence strategy in partnership with business-unit stakeholders, regulatory teams, and regional organizations, including integrated evidence planning for reimbursement submissions.
Build cross-functional partnerships and relationships with regulators, professional societies, key opinion leaders, and customers.
Translate strategic, corporate, and technical content into clear evidence roadmaps; create KPIs and three-year evidence plans for strategic initiatives.
Develop and implement clinical research strategies aligned with business goals and priorities, and set 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.
Identify process improvements and efficiencies and develop or improve standard operating procedures.
Maintain subject-matter expertise in the 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 direct reports in internal and external communications and help them consistently achieve goals and targets while reinforcing inclusion and diversity.