Director Clinical Affairs Asia Pacific - Sanzhong District

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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.

Primary Function Of Position

The purpose of the Director, Clinical Affairs- Asia Pacific is to guide, develop and execute long-term clinical evidence strategies across Asia Pacific countries (primarily for China, Japan, Korea, Taiwan, India, and others). This role will require developing guidance for Intuitive’ s pre-market submission evidence roadmaps for various clinical specialties and technology platforms in support of regulatory submissions and post- market real world evidence strategies ( development of registries , outcomes research studies , real world database utilization and scientific evidence generation with medical/surgical societies ) to drive adoption of Initiative’s platforms and technologies

As a key cross-functional constituent, this employee will work in a global matrix with functions across the organization/Region - BU/country GMs and Marketing, Global Access Value Economics (GAVE), Regulatory Affairs, Public and Govt Affairs, Clinical Development engineering, Training to optimize clinical evidence strategies to meet business objectives.

Roles And Responsibilities

Play a key role in the development of the company’s clinical and scientific strategies primarily for pre-market submission evidence roadmaps in support of regulatory submissions and post -market real world evidence generation across various product platforms and surgical specialties across Asia Pacific region.

• Lead development and execution of clinical evidence strategic roadmap and regional/in-country evidence generation plans
• As a functional leader, this role is responsible for providing strategic and tactical guidance to Asia in-country clinical affairs employees (primarily for China, Japan, Korea, Taiwan, India, and others) in execution of short and long-range evidence generation initiatives. This role will be responsible for coaching and guiding assigned team members in their internal/external communication and support direct reports in consistently achieving their goals and objectives.
• Responsible for cross-functional collaboration with various key functions within the organization to shape external environment through interactions with medical societies, medical advisory boards, regulatory agencies and external working groups.
• Lead and execute Clinical and Medical advisory initiatives by setting up advisory boards and build sustaining collaborations with medical societies, governmental agencies, and various industry panels.
• Highly skilled at translating strategic, corporate and technical content into clear evidence roadmap that effectively engages multiple functions
• Drive the development and implementation of post -market real world evidence generation across various product platforms and surgical specialties
• Lead development of pre-market submission clinical research pathways to meet regulatory submission strategies.
• Responsible for setting up effective goals that are meaningful to the department and impactful to the organization.
• Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and APAC regulatory guidelines)
• Provides solutions and efficiencies for departmental process improvements and standard operating procedures
• Effectively distills complexity and provides clear and actionable direction and information
  

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 Advanced degree in a scientific/bioengineering field (Ph. D or M.D.) or Master’s degree in a scientific/bioengineering field with minimum 12+ years of experience in clinical affairs/research project management is preferred with 4+ years of management experience
• Previous experience leading development of scientific strategies in various Asia Pacific countries (multiple countries) for pre market studies and post market real world evidence generation is required.
• Proficiency in English is required and fluency in second North Asian language such as Korean, Japanese, and Cantonese is preferred.
• Possess strong knowledge of Good Clinical Practice, ISO 14155 and other Asia in-country regulations.
• Strong understanding and background of clinical evidence pathways associated with different phases of product life cycle and formal ICH/GCP knowledge and training is essential.
• 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, collaborative, strategic thinker with excellent strategic and tactical skills with superior ability to prioritize and plan
• Prior experience in medical robotics, surgical devices and operating room is heavily preferred.
• Results-driven attitude & a resolve to win; must be self-directed with the ability to work with minimal supervision.
• Excellent interpersonal skills with emphasis on leadership with empathy, relationship development and influence management.
• Superior verbal/written communication and presentation skills, teambuilding, and interpersonal skills to work across multiple constituents.
• Must be able to travel up to 30-40%
  

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, 50 % of the Time

Travel Requirements: Yes, 50 % of the Time Shift: Shift 1 - Day