Senior Clinical Affairs Director

Our client is a top multinational medical devices and health care company with presence in US & APAC. It sells medical devices, diagnostics and other products. They are seeking for a director to take lead of the Clinical Affairs department, specifically the management of the research function and oversee the clinical research team.

Responsibilities:

• Lead the Clinical Affairs team and responsible for daily operations, resource management, budgeting, and workload prioritisation
• Be a strategic partner and advisor to senior leadership on all Clinical Affairs matters in the business
• Support clinical research related regulatory and compliance activities.
• Responsible for all Clinical Trials pertaining to medical devices with an in-depth understanding of study endpoints, patient populations, inclusion and exclusion criteria and endpoint measurement methods
• Develop new clinical trials, supervise the setting up all trials and assure that the execution of the trials complies with local regulations in all relevant territories
• Oversee the clinical research team in the generation, capture, management, analysis, and reporting of all clinical data

Requirements:

• Master in health science or medical field
• Minimum 10 years of clinical research experience required, preferably in medical device industry
• Prior experience in preparing clinical reports for regulatory submissions
• Effective leadership, management, strategic, technical, analytical, problem solving, negotiation and communication skills
• Fluent in spoken and written English and good in Chinese and Mandarin Required