Lead, Endoluminal APAC Clinical Affairs

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

• 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
• Acting as a key strategic partner to GAVE Regulatory Affairs to support regulatory approval of reimbursement new products and/or new claims
•  Manage resources and study budgets to deliver clinical studies on time within budget and in full compliance with quality standards.
• Establish and maintain strong long-term relationships with sites and principal investigators within APAC to support current and future studies
• 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
• 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 APAC market corporate procedures (e.g. SOPs 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
• 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
• 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
• Able to work in a complex cross functional environment work across multiple cultures and geographies
• Has the ability to manage priorities and deliver results while collaborating with multiple senior stakeholders across diverse functions.
• Skilled at navigating complex reporting structures and fostering strong relationships with multiple executives to ensure seamless communication and strategic alignment.
• Self starter as this is an individual contributor role which demands the ability to lead through influence rather than authority
• 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:

• Minimum Education: Advanced degree in a scientific/bioengineering field (Ph. D or M.D.) or minimum masters degree in a scientific/bioengineering field with 10 years of experience in clinical affairs/research
• 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)
• Experience in handling Sponsor Initiated investigator initiated collaborative study models
• Experience in bronchoscopy /diagnostic imaging/pulmonary medical devices although this is a preferred criteria not a mandatory criterion
• Understanding of regulatory and reimbursement procedures in 1 or more APAC markets
• Excellent clinical operation and project management skills with strong experience collaborating or leading a cross-functional team
• Strong experience with clinical study resource and budget management
• Strong experience supporting development of scientific and regulatory strategy for clinical studies
• Strong experience in developing study protocol and other study documents conducting literature review writing clinical section for regulatory submission
• Strong knowledge 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
• Strong work experience in one or more APAC markets- Taiwan/Korea/ Japan/China
• Should be comfortable visiting hospitals attending procedures
• Comfortable in a hospital environment with experience working with nurses and surgeons; existing or previous experience/familiarity with surgery/surgical technology is preferred
• Strong communication presentation and interpersonal skills with high attention to detail and organization
• Should be proficient in English verbal articulation and written communication
• 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%-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.

Remote Work :

No

Employment Type :

Full-time