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
This role is responsible for supporting, developing and implementing clinical strategies, designing and executing clinical studies in the APAC across surgical specialties and various product platforms. This role will oversee and manages clinical protocols and other key study documents in support of APAC strategic priorities ,manage clinical publications, presentations, abstracts and posters in support of key scientific research and publication needs; manage communications with clinical trial sites, CROs, KOLs and medical societies; grow, develop and manage team to interface and support all clinical requirements of the company with the applicable guidelines and regulations; foresee challenges and develops critical concepts and methodologies to overcome those.
As a key cross-functional constituent, this employee will work closely with functions across the organization – APAC commercial teams , clinical affairs teams 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 study strategies to meet business objectives.
Roles and Responsibilities
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Play a key role in the development of APAC endoluminal strategy for clinical studies to meet business goals and objectives. Collaborate with internal stakeholders (particularly within markets and GMs) and KOLs to develop and review study concepts, protocol and study outlines and subsequently drive identified initiatives
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Acting as a key strategic partner to GAVE, Regulatory Affairs to support regulatory approval of reimbursement, new products and/or new claims
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Manage resources and study budgets to deliver clinical studies on time, within budget, and in full compliance with quality standards.
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Establish and maintain strong, long-term relationships with sites and principal investigators within APAC to support current and future studies
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Work closely with data management/CROS/vendors to provide guidance on development of case report form (CRF), data cleaning to ensure collection of high-quality data
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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
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Ensure compliance with APAC market, corporate procedures (e.g., SOP’s, work instructions) and regulatory requirements (e.g., GCP and, APAC regulatory guidelines, US FDA regulations and guidelines) and responsible for ongoing review of departmental procedures and process improvement initiatives
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Responsible for setting effective goals in consultation with the manager that are meaningful to the department and impactful to the organization and in market needs
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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
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Able to work in a complex cross functional environment, work across multiple cultures and geographies
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Has the ability to manage priorities and deliver results while collaborating with multiple senior stakeholders across diverse functions.
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“Skilled at navigating complex reporting structures and fostering strong relationships with multiple executives to ensure seamless communication and strategic alignment.”
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Self starter as this is an individual contributor role which demands the ability to lead through influence rather than authority
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Additional Information (Safety Notice):
This position may involve occasional exposure to diagnostic radiation during training/case observation activities. All appropriate safety measures and protective protocols will be strictly followed in accordance with institutional and regulatory guidelines.
Qualifications
Skill/Job Requirements
Competency Requirements: (Competency is based on: education, training, skills and experience.)In order to adequately perform the responsibilities of this position the individual must have:
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Minimum Education: Advanced degree in a scientific/bioengineering field (Ph. D or M.D.) or minimum master’s degree in a scientific/bioengineering field with 10+ years of experience in clinical affairs/research
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Minimum 3-5 years of experience managing clinical studies through different study phases (pre-IDE, IDE submission, site selection and activation, study execution, data analysis and study report, and closeout)
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Experience in handling Sponsor Initiated, investigator initiated, collaborative study models
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Experience in bronchoscopy /diagnostic imaging/pulmonary medical devices, although this is a preferred criteria not a mandatory criterion
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Understanding of regulatory and reimbursement procedures in 1 or more APAC markets
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Excellent clinical operation and project management skills, with strong experience collaborating or leading a cross-functional team
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Strong experience with clinical study resource and budget management
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Strong experience supporting development of scientific and regulatory strategy for clinical studies
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Strong experience in developing study protocol and other study documents, conducting literature review, writing clinical section for regulatory submission
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Strong knowledge Good Clinical Practice, ISO14155 and other regulations/guidelines.
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Basic understanding of statistics, statistical methods, and design of experiment
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Previous experience supporting internal and external audit on clinical studies is preferred
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Excellent ability to interact with physicians and other professionals inside and outside the company
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Strong work experience in one or more APAC markets- Taiwan/Korea/ Japan/China
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Should be comfortable visiting hospitals attending procedures
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Comfortable in a hospital environment, with experience working with nurses and surgeons; existing or previous experience/familiarity with surgery/surgical technology is preferred
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Strong communication, presentation and interpersonal skills with high attention to detail and organization
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Should be proficient in English –verbal articulation and written communication
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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
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Must be able to travel up to 20%-50%
Additional Information
Intuitive는 고용 기회 균등 고용주입니다. 당사는 인종, 성별, 임신 여부, 성적 지향, 성 정체성, 출신 국가, 피부색, 연령, 종교, 국가 보훈 대상자, 장애 여부, 유전 정보 또는 연방, 주 또는 현지 관련 법률에 따라 보호받는 기타 모든 지위에 관계없이 자격을 갖춘 모든 지원자 및 직원에게 동등한 고용 기회를 제공하며 모든 유형의 차별과 괴롭힘을 금지합니다.
당사는 기회 균등법에 따라 범죄 및 유죄 판결 기록이 있는 고용 자격을 갖춘 지원자를 고려할 것입니다.
Intuitive는 고용 기회 균등 고용주입니다. 당사는 인종, 성별, 임신 여부, 성적 지향, 성 정체성, 출신 국가, 피부색, 연령, 종교, 국가 보훈 대상자, 장애 여부, 유전 정보 또는 연방, 주 또는 현지 관련 법률에 따라 보호받는 기타 모든 지위에 관계없이 자격을 갖춘 모든 지원자 및 직원에게 동등한 고용 기회를 제공하며 모든 유형의 차별과 괴롭힘을 금지합니다.
당사는 기회 균등법에 따라 범죄 및 유죄 판결 기록이 있는 고용 자격을 갖춘 지원자를 고려할 것입니다.
