Director of Clinical Affairs

Company Description

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.

Job Description

Primary Function of Position The purpose of the Director, Clinical Affairs 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 Clinical programs. 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 selected clinical programs.
• 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 implementation of pre-market submission and Post-Market clinical research strategies to meet business goals and objectives. Responsible for setting effective goals that are meaningful to the department and impactful to the organization.
• 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.
• As a functional manager, this role is responsible for effectively coaching and guiding team members in their internal/external communication and support direct reports in consistently achieving their goals and objectives while reinforcing a culture of inclusion and diversity.
• Effectively distills complexity and provides clear and actionable direction and information.

Qualifications

Required Skills and Experience

• Strategies for IDE and other premarket/post-market studies is required.
• 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, collaborative, strategic thinker with excellent project management skills and ability to prioritize and plan.
• Prior experience in medical robotics, surgical devices, and operating rooms is highly preferred.
• Results-driven attitude & a resolve to win; must be self-directed and able to work with minimal supervision.
• Excellent interpersonal skills with an emphasis on leadership, relationship development, and influence management.
• Superior verbal/written communication and presentation skills, team building, and interpersonal skills to work across multiple constituents.
• Must be able to travel up to 30-40%, including frequent travel to HQ in Sunnyvale

Required Education and Training

• Advanced degrees such as M.D, MS or PhD in the scientific/bioengineering field with 8-12 years of experience in clinical affairs/research project management is preferred, and at least 3-5 years of management experience.
• Possess knowledge of Good Clinical Practice and 21 CFR medical device regulations, ISO 14155, Med Dev/MDR regulations, and other international regulations.
• Strong understanding and background in clinical trials, study design, and formal ICH/GCP knowledge and training.

Working Conditions:

None