Primary Location: United States-California-Sunnyvale-US-CA-Sunnyvale
Requisition ID: 200387
Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.
Primary Function of Position
The purpose of the Director, Clinical Affairs- Pre Market studies/evidence is to guide, develop and execute clinical trial strategy for pre-market submission studies ( IDE ) in the US and provide strategic and tactical guidance for submission of clinical evidence dossiers to the EU notified body under new MDR guidelines. This role will require providing extensive guidance for Intuitive’s pre-market submission evidence roadmap for various clinical specialties and technology platforms in support of regulatory submissions (primarily in the US and the EU).
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 Surviellance to optimize clinical evidence strategies to meet business objectives.
This position will be responsible for development and coordination of various strategic and tactical clinical evdience generation activities to support regulatory clearance for new products and new indications.
Roles and Responsibilities
Qualifications• Play a key role in the development of the company’s clinical and scientific strategies for clinical studies primarily for pre-market submission .• Lead development and execution of clinical plans in support of clinical trials to conform to all regulatory requirements for US IDE studies .• Responsible for providing strategic and tactical guidance for Clinical evaluation report development ( CER) processes and procedures with in the framework of MDR regulations (CE Mark)• Responsible for cross functional collaboration 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• Drive the development and implementation of pre –market submission clinical research strategies to meet business goals and objectives. Responsible for setting up effective goals that are meaningful to the department and impactful to the organization.• Provide leadership and direction to the pre –market submission Clinical Affairs team. 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• As a functional manager, this role is responsible for effectively coaching and guiding assigned 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
Competency Requirements: (Competency is based on: education, training, skills and experience.)In order to adequately perform the responsibilities of this position the individual must have:
• Advanced degree in a scientific/bioengineering field (Ph. D or M.D.) or Master’s degree in a scientific/bioengineering field with 12+ years of experience in clinical affairs/research project management is preferred and at least 3-5 years of management experience
• Previous experience supporting development of scientific strategies for IDE and other pre market studies is required and prior experience of Med Dev and MDR regulations is required.
• 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 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, collaborative, strategic thinker with excellent project management skills and ability to prioritize and plan
• Prior experience in medical robotics, surgical devices and operating room is heavily preferred.
• Results-driven attitude & a resolve to win; must be self-directed with the ability to work with minimal supervision.
• Excellent interpersonal skills with emphasis on leadership, relationship development and influence management.
• Superior verbal/written communication and presentation skills, teambuilding, and interpersonal skills to work across multiple constituents.
• Must be able to travel up to 20-30%
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.