Senior Clinical Project Manager

4 weeks ago

Sunnyvale, California, United States Intuitive Surgical Full time
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 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.
  • Effectively distills complexity and provides clear and actionable direction and information.

  • Senior Project Manager

    3 weeks ago

    Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionThe Senior Project Manager is part of the PMO and organizes a diverse set of activities of the Program Management Office within the New Product Development organization. The PMO group is accountable for leading cross functional teams developing for new products, and consists of project managers, program managers and project coordinators. The...

  • Senior Project Manager

    1 month ago

    Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position The Senior Project Manager, Regulatory Business Systems will work closely with Regulatory, Product Quality, Compliance, and IT organizations. This Senior Project Manager role will manage quality and regulatory business system projects ensuring the product vision, priorities, and solutions are actively serving the...

  • Senior Project Manager

    2 weeks ago

    Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position:The Sr. Project Manager is accountable for providing cross-functional project management on behalf of the Global Services organization in help of new product development/introduction, and executing on key strategic initiatives.The Sr. Project Manager serves as the primary liaison between ISI's Engineering teams /...

  • Senior Project Manager

    1 month ago

    Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position:The Sr. Project Manager is responsible for providing cross-functional project management on behalf of the Global Services organization in support of new product development/introduction, and executing on key strategic initiatives. The Sr. Project Manager serves as the primary liaison between ISI's Engineering teams...

  • Senior Project Manager

    4 weeks ago

    Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position:Intuitive Surgical designs and manufactures highly complex surgical systems including cameras, instruments, and accessories for use in surgery. We are looking for an individual to manage Robotic Assisted Surgical Devices projects associated with the development of these products.Development of...

  • Senior Content Manager

    1 day ago

    Sunnyvale, California, United States Hogarth Full time

    Hogarth is the Global Content Experience Company. Part of WPP, Hogarth partners with one in every two of the world's top 100 brands including Coca-Cola, Ford, Rolex, Nestlé, Mondelez and Dyson. With a breadth of experience across an extensive range of sectors, Hogarth offers the unrivaled ability to deliver relevant, engaging, and measurable content across...

  • Manager Clinical Development Engineering

    4 weeks ago

    Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of PositionThe Clinical Development Engineering team at Intuitive Surgical holds a unique position within product development by identifying clinical value through enabling the safe, effective, and reliable use of surgical robotic platforms and their components.The Clinical Development Engineering Manager (Post Market) will...

  • Senior Human Factors Engineer

    4 weeks ago

    Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of PositionThe Senior Human Factors Engineer collaborates with various teams to develop new products that are practical, profitable, and appealing.As part of product-development teams, the Senior Human Factors Engineer plays a key role in user-centered design research. They examine use-related risks, conduct usability testing,...

  • Managing Staff Product Engineer

    2 days ago

    Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of PositionOur Accessories interface between all aspects of the da Vinci system and enable safe and effective robot-assisted surgery. They may be reusable or single-use medical devices (consumables). Our customers interact directly with Accessories in every surgical procedure, and they serve a critical role in customer...

  • Program Manager Endoluminal BU SW

    4 weeks ago

    Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position:This role will be reporting to the Endoluminal PMO Manager, you will be accountable for the management of both New Product Development (NPD) and Sustaining projects for the Endoluminal Business Unit. You will be aligning engineering, clinical, and regulatory schedules, to ensuring that the right products are...

  • Senior Manager Technical Accounting Advisory

    2 weeks ago

    Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of PositionThe Senior Manager Technical Accounting Advisory & Policies plays a critical role in achieving our overall goal of delivering world-class financial reporting. This highly visible role frequently interacts with executive management as part of providing technical accounting advice.This role offers a great opportunity...

  • Senior Manager Technical Accounting Advisory

    2 weeks ago

    Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionJob DescriptionPrimary Function of PositionThe Senior Manager, Technical Accounting Advisory & Policies plays a critical role in achieving our overall goal of delivering world-class financial reporting. This highly visible role frequently interacts with executive management as part of providing technical accounting advice.This role offers a...

  • Senior Mechanical Design Engineer

    3 weeks ago

    Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of PositionThe Future Forward group within Intuitive Surgical is searching for a Senior Mechanical Design Engineer with a focus on the development of new instruments, contributing to the exploration of a novel concept for a new application of surgical robotics from proof of concept through detailed mechanical design, prototype...

  • Senior Mechanical Engineer Catheters

    5 days ago

    Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position The Future Forward group within Intuitive Surgical is searching for a Senior Mechanical Engineer with a focus on the development of new catheter instruments, contributing to the exploration of a novel concept for a new application of surgical robotics from proof of concept through detailed mechanical design,...

  • Technical Project Manager

    1 month ago

    Sunnyvale, California, United States QData Full time

    Responsibilities & Duties Owns and manages the Business Req Documentations Software Req Specifications along with the dev team and the Functional Req Specifications. Develop a clear understanding of the customer needs and documents it. Clearly articulates and clarifies detailed business requirements that are intended for engineering and user interface design...

  • Business Program Manager

    1 month ago

    Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of PositionThis exciting role sits in the Global Business Services Program Management Office (PMO), delivering effective and efficient programs and services through Program Management, Business Improvement and M&A Integration. This role will report to the Director of M&A Integration and will contribute to Intuitive's success...

  • Senior Mechanical Design Engineer

    3 days ago

    Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position Our Accessories interface between all aspects of the da Vinci system and enable safe and effective robot-assisted surgery. They may be reusable or single-use medical devices (consumables). Our customers interact directly with Accessories in every surgical procedure, and they serve a critical role in customer...

  • Human Factors Manager

    1 month ago

    Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position: The Human Factors Manager collaborates with team members, designers, and engineers. They also work with cross-functional partners to support Human Factors team development. The manager represents the Human Factors function in business units for safety, usability, and regulatory compliance. They support and ensure...

  • Senior Human Factors Engineer

    1 month ago

    Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position As part of the Intuitive Human Factors team, the Sr. Human Factors Engineer works closely with designers, clinical engineers, system and software engineers, technical product managers, regulatory affairs, and other important functional teams. The Sr. Human Factors Engineer is a key contributor in informing and...

  • Senior Software Engineer

    2 days ago

    Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position:The Core Technologies Engineering (CTE) group within Intuitive has an immediate opening for a dedicated C/C++ Code Quality expert to join our team in Sunnyvale, CA. The ideal candidate will possess deep knowledge of C/C++ development standards and extensive experience improving code quality. This role requires...