Director of Clinical Operations
Position: Director of Clinical Operations
Department: Clinical Research & Development (CRD)
Report to: VP of CRD
About Hua Medicine
Hua Medicine is a leading clinical-stage, innovative drug development company in China, focusing on novel therapies for the treatment of diabetes and CNS disorders.
- Job introduction
The Clinical Operations Director is a key member of Clinical Research & Development Department. In this position, the Clinical Operations Director is responsible for leading and manage the clinical operation team and provides leadership, strategic direction and oversight for all study, people and stakeholder management activities conducted by his/her team. The Clinical Operations Director will ensure clinical trials conducted in China within defined budget and timeline. He/she will lead the process of vendor selection and contract negotiation. The Clinical Operations Director is responsible to ensure that all the operational activities to have good adherence to ICH-GCP, Chinese legal/regulatory requirements and Hua's policies and SOPs.
- a) Strategic Direction:
• Develops the strategy and drives implementation of tactics for Clinical Operations to meet both long-term and annual goals of the company.
• Proactively implements measures to ensure the effective delivery of clinical studies, including preparation for the conduct of studies in existing and new Therapeutic Areas, as required by the development pipeline.
• Oversee the initiation and conduct of clinical trials by CROs ensuring timely recruitment and finalization.
• Select and manage suitable third party for out-sourced services (such as clinical research organization, central laboratories, data management, statistical analysis) necessary for the operation of clinical trial.
• Organize, initiate, monitor and manage clinical trials according to China Good Clinical Practice (cGCP) and ICH-GCP, Hua's SOPs and other relevant clinical research guidelines.
• Identifies and implements strategies and tactics to ensure continuous productivity and efficiency gains, and a high performing clinical operations team.
• Accountable for ensuring clinical operation budget forecasts are accurately produced and submitted in time for the functional budget rounds. Ensures adherence to budget forecasts.
- b) People Management:
• Develops a highly motivated team through effective leadership, coaching and people management, ensuring an objective and performance-led management culture.
Accountable for resource management, performance management and career development of Clinical Operations staff.
- c) Stakeholder Management:
• Ensures effective collaboration either directly or through others with investigators, ethics committees, clinical research networks, patient groups and, as required, local Health Authorities, in compliance with company policies and country legislation.
• Develops and maintains excellent relationships and interactions between the Clinical Operations team, Medical team, safety, and other functions.
- • Master degree in medicine, pharmacy or other life sciences, MD/Ph.D. is a plus.
• Minimal 5 years of international pharmaceutical industry experience in clinical study planning, execution activities as senior manager/director of clinical operations.
• Good leadership skills and can inspiring other people.
• Strong insight of the overall drug development process, clinical trial methodology, China regulatory environment, ICH/GCP Guidelines and International regulations
• Fluent in both English and Chinese
• Good communication and interpersonal skills - works well with others, motivates and encourages
• Proficiency in computer skills, CTMS
• The ideal candidate is required to have experiences in clinical operations in multi-national companies. Previous Experiences in involving global or regional trials are preferable.
• Availability to travel nationally and internationally