Director Clinical Affairs

Company Description

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 purpose of the Clinical Project Director, Fluorescence Imaging, is to initiate and oversee clinical trials for fluorescence imaging agents developed by Intuitive Surgical under an Investigation New Drug (IND) application. Clinical development will focus on late-stage clinical trials, primarily Phase 3 pivotal trials. The Clinical Project Director will provide oversight of multiple drug development programs, managing an internal clinical team as well as external Contract Research Organizations (CROs) and consultants tasked with study operations. This employee will be responsible for clinical study reports and study data deliverables, working closely with Regulatory Affairs in preparing and submitting New Drug Applications (NDAs). This position will liaise with internal teams including Regulatory Affairs, Quality, Manufacturing, Clinical Development Engineering, Document Controls, Global Access Value Economics (GAVE), Statistics, and Medical Officers. While the role focuses on clinical development of pharmaceutical fluorescence imaging agents, these drugs are visualized on Intuitive devices; the ideal candidate will have a working understanding of 510(k)s, design controls, and medical device development. The employee will both develop and ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and FDA guidelines).

Roles and Responsibilities

• This role will report to the VP & Business Leader of Intuitive Fluorescence Imaging
•  The role will assume leadership of the company’s clinical, operational, and scientific strategies for clinical studies to support pre-market submission in US IND studies for Intuitive’s fluorescence imaging agents.
• Management of Phase 3 programs, overseeing outsourced responsibilities to CROs.   Role will require both broad oversight of the clinical development program and hands-on management of key aspects.
• Oversee clinical components of NDA submission packages; responsible for final study reports, study data in FDA Data Standards, and ensuring a high state of compliance for any regulatory audits.
• Lead development and execution of clinical plans in support of clinical trials to conform to all regulatory requirements for US IND studies.
• Responsible for developing and maintaining the overall clinical Quality Management System framework, processes, and standard operating procedures for the Fluorescence Imaging IND programs.
• Responsible for cross-functional collaboration with various key functions within the organization
• Highly skilled at translating strategic, corporate, and technical content into clear evidence roadmap that effectively engages multiple functions.
• 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.
• Provide leadership and direction to the Fluorescence Imaging clinical team.
• 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.
• As a functional manager, this individual is responsible for effectively c