Director of Clinical Affairs Endoluminal

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. Primary Function of Position The Director, Clinical Affairs- Endoluminal will guide, develop and execute long range clinical trial strategies, inclusive of first human use, regulatory studies and post-market evidence generation and provide strategic guidance and oversight for global clinical evidence strategies for Intuitive’s Endoluminal Business unit. Additionally, this role will a global vision for emerging markets and partner with representatives from other business units for process alignment. As a key cross-functional constituent, this employee will work in a global matrix with teams across the Endoluminal Medical Officers, R&D, New and sustaining product development, Clinical Development engineering, Regulatory Affairs, Regulatory compliance, Post Market Surveillance, Global Access Value Economics (GAVE), and Global Public Affairs (GPA) to optimize clinical evidence strategies to meet business priorities. This position will be responsible for development and coordination of various strategic and tactical clinical evidence generation activities to assist with regulatory clearance for new products and new indications Roles and Responsibilities Play a lead role in the development of the company’s clinical and scientific strategies, including clinical studies for new product development (first human use and/or IDE studies), post-market evidence generation or emerging markets for Intuitive’s Endoluminal technology. Steer development and execution of clinical plans in aid of clinical trials to conform to applicable regulatory requirements (e.g. MDR, GCP or ISO 14155). Responsible for providing strategic guidance to global clinical evidence strategy for the Endoluminal program with exceptional partnership with the business unit and GAVE representatives, including integrated evidence planning and execution for reimbursement submissions Responsible for cross functional partnership with various key functions within the organization to shape external environment through interactions with notified body and regulatory agency and external working groups. Highly skilled at translating strategic, corporate and technical content into clear evidence roadmap that effectively engages multiple functions. Creates key performance indicators (KPI) and 3-year evidence plans in aid of strategic initiatives for the Endoluminal Business Unit Drive the development and implementation of clinical research strategies to meet business goals and priorities. Responsible for setting up effective goals that are meaningful to the department and impactful to the organization. Accountable and accountable for year over year program budgets related to clinical trials Provide leadership and direction to the broader Clinical Affairs team as needed. Addresses current and future opportunities and issues to ensure sustainable success 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 Subject matter expert in the literature landscape and clinical outcomes for procedures related to Endoluminal Technologies Contributes to market intelligence relative to clinical outcomes for both Intuitive and competitor technologies. Contributes to, reviews and approves key clinical documents and plans, including but not limited to: Clinical Investigation Plans, Clinical Study Reports, and Post-Market Clinical Follow-up (PMCF) plans As a functional manager, this role is responsible for effectively coaching and guiding team members in their internal/external communication and aid direct reports in consistently achieving their goals and targets while reinforcing a culture of inclusion and diversity. Skill/Job Requirements Requirements: are based on education, training, skills and experience. In order to adequately perform the responsibilities of this position the person must have: Advanced degree such as M.D, MS or PhD in scientific/bioengineering field with minimum 8 years of experience in clinical affairs/research project management is preferred and minimum 3 years of management experience. Relevant job experience combined with technical degree and/or master's degree may qualify. Previous experience assisting with the development of scientific strategies for IDE, pre-market (e.g. First human use) and/or post-market evidence generation is required Possess knowledge of Good Clinical Practice and 21 CFR medical device regulations, ISO 14155, Med Dev/MDR regulations and other international regulations. Solid knowledge and background of clinical trials, study design and formal ICH/GCP knowledge and training 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, cooperative, strategic thinker with excellent project management ski