Sr. Director, Clinical Affairs - Endoluminal

About the role

Primary Function of Position

The Senior Director, Clinical Affairs- Endoluminal will guide, develop and execute long range clinical evidence 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.

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 and dissemination 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.
• Accountable for development and execution of clinical study plans 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 in partnering with key business unit stakeholders: medical officers need to spell what GAVE is external people will not know, regulatory, regional organization, ensuring comprehensive integrated evidence planning and execution for reimbursement submissions

Additional information

*Responsible for cross functional partnerships with various key functions within the organization to build strong relationships with regulators, societies, KOLs, and customers.

*Highly skilled at translating strategic, corporate and technical content into clear evidence of 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 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

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

*Advanced degrees such as M.D, MS or PhD in scientific/bioengineering field with 8-12 years of experience in clinical affairs/research project management are preferred and at least 3-5 years of management experience. Relevant job experience combined with a 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 highly 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

Additional Information

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

Mandatory Notices

U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process).

For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee's start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

This position may be filled at a different job level than listed here depending on business need and/or on the selected candidate's experience, knowledge and skills.

Compensation will be based primarily on the job level at which the role is filled and the candidate's qualifications, consistent with applicable law.

Accommodation & Accessibility Notice

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.