Clinical Affairs Head Taiwan

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

As the lead country clinical affairs employee, this role is responsible for developing and implementing evidence strategies, including but not limited to; company sponsored studies, IIT (Investigator Initiated Trials), society driven registries, RWE analysis (Real world Evidence). Responsible for designing and executing evidence strategies   across surgical specialties and various product platforms. This role is responsible for driving the development and implementation of clinical research/evidence generation strategies to meet business goals and objectives. Develop and support all clinical and medical affairs needs of the company with the applicable local guidelines and regulations.

Essential Job Duties

• Responsible for monitoring publication landscape to stay abreast of scientific knowledge and market trends through regular review of scientific literature to help develop clinical evidence strategies
• Identify evidence gaps and market opportunities to design and execute evidence strategies to meet local evidence needs and to support reimbursement initiatives
• Contribute to the development and implementation of clinical and medical strategies to meet business goals and objectives. Responsible for conducting evidence generation initiatives (company sponsored studies, IIT (investigator initiated trials) , society driven registries , RWE ( Real world Evidence) analysis ) on schedule and within budget while ensuring high quality and compliance
• Collaborate with commercial function to understand market trends and utilize information to support of business goals through Clinical Affairs activities
• Collaborate with key internal stakeholders such as Regulatory Affairs (RA), Global Access Value Economics (GAVE), Global Public Affairs (GPA), Commercial functions and external stakeholders such as advisory boards, KOLs, and various medical/surgical societies to develop evidence generation strategies, to review evidence concepts, to develop study/evidence designs and subsequently to implement these initiatives. 
• Responsible for the planning and execution of site selection, investigator selection, analysis of potential patient recruitment, supporting the creation of study related documents (including protocols, case report forms, Informed consents, Clinical trial agreements), organizing IRB/EC submissions with follow thorough to ensure successful outcome
• Participate in data analysis, interpretation and synthesis, instruction to develop Clinical study report and /or support development of scientific publications.
• Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements.
• Author, review and revise Clinical Operations Standard Operating Procedures (SOPs) for the region/country.
• Provides in-depth understanding of the importance of metrics and milestones
• Responsible for managing budgets and other resources in a consistently effective and efficient manner
• Routinely solves complex problems that enable the team to make significant progress

Qualifications

Required Skills and Experience

• Previous experience supporting development of scientific publication strategy
• Significant knowledge of clinical and outcomes research study design
• Strong experience in conducting literature searches, reviews, and appraisal of the scientific data
• Excellent ability to interact with physicians and other professionals inside and outside the company
• Strong experience in protocol development and medical writing
• Possess knowledge of Good Clinical Practice and 21 CFR Part 11 and Taiwan regulations
• Comfortable in a hospital environment, with experience working with nurses and surgeons
• Strong understanding and background of clinical trials, study design and some formal ICH/GCP knowledge and training
• Basic understanding of statistics, statistical methods, and design of experiment
• Must be able to work effectively on cross-functional teams and in a matrix environment
• Ability to build things from scratch, identify key stakeholders, influence them, be an advocate for Taiwan and get things done
• Must be able to manage multiple projects
• Strong communication, presentation, and interpersonal skills with high attention to detail and organization
• Ability to learn quickly and self-educate on different surgical specialties as applicable to clinical projects (Self-starter attitude)
• Consistently shows dedication or strong work-ethic to help meet aggressive timelines or multiple projects when necessary
• Should be able to understand business needs and be able to work in a matrix environment to deliver objectives, should be self-driven and proactive
• Strong understanding of country healthcare systems
• Entrepreneurial mindset, ability to take risks
• Fluent in Mandarin and English
• Must be able to travel 20%-35%(predominantly within country)

Required Education and Training

• Advanced degree in a scientific/bioengineering field (Ph. D or M.D.) or Master’s degree in a scientific/bioengineering field with 7+ years of experience in clinical affairs/research project/medical affairs management is preferred

Preferred Skills and Experience

• Preference given to candidates with existing experience or familiarity with surgery/surgical technology 

Additional Information

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.