Director of Clinical Affairs Endoluminal

Job description

Job responsibilities

• Play a lead role in the development of the company’s clinical and scientific strategies, including clinical studies for new product development (first human use and/or IDE studies), post-market evidence generation or…
• Steer development and execution of clinical plans in aid of clinical trials to conform to applicable regulatory requirements (e.g. MDR, GCP or ISO 14155).
• Responsible for providing strategic guidance to global clinical evidence strategy for the Endoluminal program with exceptional partnership with the business unit and GAVE representatives, including integrated evidence…
• Responsible for cross functional partnership with various key functions within the organization to shape external environment through interactions with notified body and regulatory agency and external working groups.
• Highly skilled at translating strategic, corporate and technical content into clear evidence roadmap that effectively engages multiple functions. Creates key performance indicators (KPI) and 3-year evidence plans in aid
• of strategic initiatives for the Endoluminal Business Unit
• Drive the development and implementation of clinical research strategies to meet business goals and priorities. Responsible for setting up effective goals that are meaningful to the department and impactful to the…
• Accountable and accountable for year over year program budgets related to clinical trials

Job requirements

• Advanced degree such as M.D, MS or PhD in scientific/bioengineering field with minimum 8 years of experience in clinical affairs/research project management is preferred and minimum 3 years of management experience.
• Previous experience assisting with the development of scientific strategies for IDE, pre-market (e.g. First human use) and/or post-market evidence generation is required
• Possess knowledge of Good Clinical Practice and 21 CFR medical device regulations, ISO 14155, Med Dev/MDR regulations and other international regulations.
• Solid knowledge and background of clinical trials, study design and formal ICH/GCP knowledge and training
• Proven track record of leadership by example and developing high performing teams
• Excellent ability to interact with physicians and other professionals inside and outside the company.
• Entrepreneurial, cooperative, strategic thinker with excellent project management skills and ability to prioritize and plan
• Prior experience in medical robotics, surgical or flexible catheter devices and operating room settings is heavily preferred.