Senior Clinical Project Manager

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 Senior Clinical Project Manager role requires a candidate with a multifaceted skillset focused on clinical trials strategy and execution, with a demonstrated ability to navigate a pharmaceutical product successfully through development to market in US/OUS regions. The Senior Clinical Project Manager will oversee clinical trials for fluorescence imaging agents developed by Intuitive Surgical under an Investigation New Drug (IND) application, while strategizing development plans for pharmaceutical products in OUS geographies (e.g., APAC regions). The ideal candidate must have international clinical operational experience and be well versed in working collaboratively with international Contract Research Organizations (CROs), consultants, and internal stakeholders to ensure the success of clinical programs. Candidates should be familiarized with terminal clinical development planning encompassing pivotal clinical trials. Experience integrating clinical study reports, Study Data Tabulation Models, risk-benefit analyses, and other clinical work product into regulatory deliverables including drug applications in the US/OUS is required.

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 employee will both develop and ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP, US, and OUS guidelines).

Essential Job Duties

• This role reports to the Director of Clinical Affairs for Intuitive Fluorescence Imaging.
• Play a lead role in the development of the company’s clinical, operational, and scientific strategies for clinical studies for pre-market submission into US submissions.
• Management of US/OUS clinical programs, overseeing outsourced responsibilities to CROs and business partners.
• 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.
• Lead clinical development strategies in OUS geographies, primarily focused on APAC regions, with the capacity to establish new operational procedures that ensure compliant pharmaceutical development these regions.
• Identify OUS CROs and other development partners that can successfully execute clinical operations within these geographies.
• Work closely with regulatory affairs to create OUS drug application submission strategies supported by a combination of US/OUS clinical trial safety and efficacy datasets.
• Maintain 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 effec