Director Clinical Affairs Single Port (based in Sunnyvale, CA)

Company Description

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 market leader in 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.

Job Description

Primary Function of Position

The purpose of the Director, Clinical Affairs- Single Port 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 Single Port (SP) Surgery program.

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 the SP program.
• 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