About the position
The Director, Clinical Affairs- Endoluminal will guide, develop and execute long range clinical trial strategies, inclusive of first human use, regulatory studies and post-market evidence generation and provide strategic guidance and oversight for global clinical evidence strategies for Intuitive's Endoluminal Business unit. Additionally, this role will have a global vision for emerging markets and partner with representatives from other business units for process alignment. As a key cross-functional constituent, this employee will work in a global matrix with teams across the Endoluminal Medical Officers, R&D, New and sustaining product development, Clinical Development engineering, Regulatory Affairs, Regulatory compliance, Post Market Surveillance, Global Access Value Economics (GAVE), and Global Public Affairs (GPA) to optimize clinical evidence strategies to meet business priorities. This position will be responsible for development and coordination of various strategic and tactical clinical evidence generation activities to assist with regulatory clearance for new products and new indications.
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.
- Steer development and execution of clinical plans in aid 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 exceptional partnership with the business unit and GAVE representatives, including integrated evidence planning and execution for reimbursement submissions.
- Responsible for cross functional partnership 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 aid of strategic initiatives for the Endoluminal Business Unit.
- Drive the development and implementation of clinical research strategies to meet business goals and priorities. Responsible for setting up effective goals that are meaningful to the department and impactful to the organization.
- 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 market 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 aid direct reports in consistently achieving their goals and targets while reinforcing a culture of inclusion and diversity.
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 assisting with the 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.
- Solid knowledge 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, cooperative, strategic thinker with excellent project management skills and ability to prioritize and plan.
- Prior experience in medical robotics, surgical or flexible catheter devices and operating room settings is heavily preferred.
- Results-driven attitude & a resolve to win; must be self-directed with the ability to work with minimal supervision.
- Excellent relational skills with emphasis on leadership, relationship development, employee development and influence management.
- Excellent verbal/written communication and presentation skills, teambuilding, and relational skills to work across multiple constituents.
- Must be able to travel up to 30-40%, including international travel as needed.
