Director – Clinical Affairs – Endoluminal

Director – Clinical Affairs – Endoluminal

Requirements

• Advanced degree such as M.D, MS or PhD in 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.
• Previous experience supporting 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.
• 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.
• 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, employee 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 30-40%, including international travel as needed.

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.
• Lead development and execution of clinical plans in support 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 strong collaboration with the business unit and GAVE representatives, including integrated evidence planning and execution for reimbursement submissions.
• 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. Creates key performance indicators (KPI) and 3 year evidence plans in support of strategic initiatives for the Endoluminal Business Unit.
• Drive the development and implementation of 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.
• Responsible 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 competitive 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 support direct reports in consistently achieving their goals and objectives while reinforcing a culture of inclusion and diversity.

Preferred Qualifications

• Prior experience in medical robotics, surgical or flexible catheter devices and operating room settings is heavily preferred.