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Manager Clinical Affairs

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IntuitiveSunnyvale, CA
  • At Intuitive, 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.
  • Our mission is our guiding force; our culture is the DNA that makes us unique.
  • As a pioneer in robotic-assisted surgery (RAS), we have been expanding our innovations through technology to help make a difference in the world.
  • For 25 years, human ingenuity has guided our journey to help solve some of healthcare’s complex challenges.
  • We believe a great idea can come from anywhere—inclusion and mutual respect are vital to our culture.
  • We value character grounded in integrity, a strong capacity to learn, the energy to get things done, and diverse 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 strive to 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 help to advance the world of minimally invasive care.
  • Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.
  • As a functional manager of Clinical Affairs, this role is responsible for developing and implementing clinical strategies, designing and executing clinical studies for pre-market submission studies (IDE) in the US across surgical specialties and various product platforms.
  • As a key cross-functional constituent, this employee will work closely with functions across the organization – Regulatory Affairs, R&D, Program Management Office (PMO), Clinical Development Engineering (CDE), Global Access Value Economics (GAVE), Global Public Affairs ( GPA), Regulatory Compliance , Training, Legal, and commercial functions to optimize clinical sudy strategies to meet business objectives.
  • Play a key role in the development the company’s IDE clinical strategy for US pre-market submissions to meet business goals and objectives.
  • Collaborate with internal stakeholders and KOLs to develop and review study concepts, protocol and study outlines and subsequently driving identified initiatives
  • Acting as a key strategic partner to Regulatory Affairs through close interactions with FDA during the pre-IDE, IDE submission to support regulatory approval of new products and/or new claims
  • Responsible for managing resource and study budget to ensure IDE studies are conduced on schedule and within budget while ensuring high quality and compliance
  • Build strong and sustaining relationship with investigational sites and investigators for ongoing and future IDE studies
  • Work closely with data management to provide guidance on development of case report form (CRF), data cleaning to ensure collection of high quality data
  • Work closely with Biostats in study design, developing statistical analysis plan (SAP), analysis, interpretation and synthesis in order to develop Clinical Study Report and /or support development of scientific publications
  • Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US FDA regulations and guidelines) and responsible for ongoing review of departmental procedures and process improvement initatives
  • Responsible for setting up effective goals that are meaningful to the department and impactful to the organizations
  • Provide functional manager leadership to direct reports and provide ongoing guidance for the assigned team members in their internal/external communication and support direct reports in consistently achieving their goals and objectives
  • Sets and hold individual and team accountable for high standard of competencies and overall performance
  • Effectively distills complexity and provides clear and actionable direction and information, help team prioritize, solve complex problems that enable the team to make significant progress
  • Develop talents, build a highly capable and effective team of clinical study managers (CSM) and clinical research associates (CRA) to manage IDE studies
  • Competency Requirements: (Competency is based on: education, training, skills and experience.)
  • Minimum Education: Advanced degree in a scientific/bioengineering field (Ph. D or M.D.) or Master’s degree in a scientific/bioengineering field with 10+ years of experience in clinical affairs/research and at least 2-4 years of management experience
  • Minimum 3-5 years of experience managing IDE studies through different study phases (pre-IDE, IDE submission, site selection and activation, study execution, data analysis and study report, and closeout)
  • Excellent clinical operation and project management skills, with strong experience collaborating or leading a cross-fuctinal team
  • Strong experience with clinical study resource and budge management
  • Strong experience supporting development of scientific and regulatory strategy for IDE studies
  • Strong experience in developing study protocol and other IDE study documents, conducting literature review, writing clinical section for regulatory submission
  • Strong knowledge of 21 CFR part 812 , Good Clinical Practice, ISO14155 and other regulations/guidelines.
  • Basic understanding of statistics, statistical methods, and design of experiment
  • Previous experience supporting internal and external audit on clinical studies is preferred
  • Excellent ability to interact with physicians and other professionals inside and outside the company
  • Comfortable in a hospital environment, with experience working with nurses and surgeons; existing or previous experience/familiariry with surgery/surgical technology is preferred
  • Strong communication, presentation and interpersonal skills with high attention to detail and organization
  • Results-driven attitude and strong problem solving skills, consistently shows dedication or strong work-ethic to help meet aggressive timelines or multiple projects when necessary
  • Must be able to travel up to 20-30%
  • Details can vary by role.
  • Intuitive is an Equal Employment Opportunity Employer.
  • We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
  • We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
  • Shift : Shift 1 - Day
  • Travel : Yes, 25 % of the Time
  • Travel Requirements:Yes, 25 % of the Time Shift:Shift 1 - Day

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