Director, Clinical Affairs - Endoluminal

Director, Clinical Affairs - Endoluminal

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 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 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.

Roles and 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 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 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.

Qualifications

Skill / Job Requirements

Requirements : are based on education, training, skills and experience. In order to adequately perform the responsibilities of this position the person must have :

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. Relevant job experience combined with technical degree and / or master's degree may qualify.

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