Sr. Director, Clinical Affairs - Endoluminal

Job Description

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.

Essential Job Duties:

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

•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.

Qualifications

Core Competencies and Skill Requirements:

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

…