Director Clinical Affairs

Primary Function of Position: This role is responsible for developing and executing short-term and long-range clinical study strategies and plans to support premarket and postmarket clinical evidence needs for assigned Intuitive products and European markets.  As a key cross-functional constituent, this employee will work in a global matrix with functions across the organization/Region – BU/country GMs and Marketing, Medical Affairs, Market Access, Regulatory Affairs, Global Public Affairs to optimize clinical evidence strategies to meet business objectives.  This position will be responsible for leading teams to develop and coordinate various strategic and tactical clinical evidence generation and dissemination activities, including the development of outcomes research studies, manuscripts, registries, collaborative studies, scientific evidence generation with medical/surgical societies, and investigator-initiated studies.  Roles and Responsibilities: - Drives the development and implementation of clinical evidence strategies to meet business goals and objectives for European markets. - Responsible for effective cross-functional collaboration within a global matrix including interactions with EU Region/Country commercial leaders, Marketing, Medical Affairs, Market Access, Regulatory Affairs, Finance, Legal, Global Public Affairs to facilitate European program/project strategies. - Highly skilled at translating strategic, corporate and technical content into clear evidence roadmap that effectively engages multiple functions. - Effective in providing strategic direction and establishing priorities that balance short-term and long-term business needs.  Ensures the function and team consistently meets its targets, goals, and objectives, while keeping an eye on the future and how current results affect and support future needs and evolutions. - Responsible for establishing effective goals that are meaningful to the department and impactful to the organization. - Oversee European clinical research activities for assigned areas of responsibility with minimal supervision including company sponsored studies, collaborative studies, investigator-initiated studies and scientific evidence generation with medical/surgical societies. - Build relationships with KOLs, hospitals, medical/surgical societies to support clinical evidence planning, generation, and dissemination. - 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 and reports. - As a functional manager, this role is responsible for effectively hiring and developing the clinical affairs staff, while coaching and guiding the overall team members in their internal/external communication and providing support to direct reports to consistently achieve their goals and objectives, while reinforcing a culture of inclusion, diversity and team spirit. - Provide leadership and direction to the broader Clinical Affairs organization as needed - Ensure compliance with corporate (e.g., SOP’s) and regulatory (e.g., GCP, EU MDR, US FDA, data protection) requirements. - Provides solutions and efficiencies for departmental process improvements, standard operating procedures and quality initiatives. At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and leading company in the field of robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare’s hardest challenges and advance what is possible. Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. Passionate people who want to make a difference drive our culture—our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real-world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.  Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let’s advance the world of minimally invasive care.