Responsibilities
- Support, develop and implement clinical strategies across surgical specialties and various product platforms in APAC.
- Design and execute clinical studies in APAC.
- Oversee and manage 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 applicable guidelines and regulations.
- Foresee challenges and develop critical concepts and methodologies to overcome those.
- 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.
- Act 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., 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.
- 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.
Requirements
- Experience in developing and implementing clinical strategies in the APAC region.
- Proven ability to design and execute clinical studies across surgical specialties and product platforms.
- Experience managing clinical protocols, study documents, publications, presentations, abstracts, and posters.
- Strong experience managing communications with clinical trial sites, CROs, KOLs, and medical societies.
- Demonstrated ability to grow, develop, and manage teams in compliance with regulations and guidelines.
- Proven ability to foresee challenges and develop methodologies to overcome them.
- Experience collaborating with internal stakeholders and KOLs to develop and review study concepts, protocols, and study outlines.
- Experience acting as a strategic partner to GAVE and Regulatory Affairs for regulatory approval, reimbursement, new products, or new claims.
- Proven ability to manage resources and study budgets to deliver clinical studies on time, within budget, and in compliance with quality standards.
- Established relationships with clinical trial sites and principal investigators in APAC.
- Experience working with data management, CROs, and vendors on case report form (CRF) development and data cleaning.
- Collaboration experience with Biostats on study design, statistical analysis plans, analysis, interpretation, and Clinical Study Report development.
- Compliance expertise with APAC market regulations, corporate procedures (e.g., SOPs), GCP, APAC regulatory guidelines, and US FDA regulations.
- Ability to set effective, impactful goals in consultation with management.
- Ability to distill complexity and provide clear, actionable direction and problem-solving support to teams.
- Proven ability to work in complex, cross-functional environments across multiple cultures and geographies.
- Ability to manage priorities and deliver results while collaborating with senior stakeholders across diverse functions.
- Skilled at navigating complex reporting structures and building relationships with executives for strategic alignment.
- Self-starter with ability to lead through influence in an individual contributor role.
Work Arrangement
Remote (Country) — APAC
Team
Structure: Cross-functional collaboration with 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.
Additional Information
- 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.
