Vice President of Clinical Operation
- This is an exciting opportunity to join a biotech start-up company committed to developing innovative gene therapies for the treatment of rare and chronic diseases.
- The vice president of Clinical Operation is to be responsible for formulate the clinical development strategy and driving the successful implementation of assigned Clinical Trial projects with regards to timeline, budget and quality.
- The successful candidate will be involved with working on innovative and pioneering advanced therapies to treat rare and chronic diseases and benefit from working with cutting edge technologies and be the key player in the clinical development and advancing company’s innovative portfolio of products.
- Establish the company's US clinical research department, responsible for the US and global clinical development of innovative drugs in rare and chronic diseases (e.g., ophthalmic, blood, neuromuscular) therapeutically area.
- Assist CMO to formulate R&D strategy, formulate and be responsible for the implementation, process identification and decision-making of clinical development strategy and plan;
- Responsible for the progress, quality and funding management in the clinical research, and promptly guide the solution of major problems in the project progress;
- Lead the communication and coordination with project partners, domestic and foreign clinical experts, CRO, and relevant personnel of the drug regulatory department to adjust the clinical strategy and plan of the project in a timely manner, and promote the smooth completion of the project and meet the requirements of ICH- GCP, SOP and local laws and regulations requirements;
- Provide cross-functional support (e.g., RA, BD, R&D) with trial relevant expertise when necessary.
Required Education, Experience, Skills & Competencies
- Master degree (advanced degree preferred) in a life science field (e.g., Medicine, Biology, Pharmaceutical sciences)
- 15 + years Clinical research experience, with track record in planning and managing registration clinical trials, familiar with rare and chronic diseases (e.g., ophthalmic, blood, neuromuscular) therapeutically area can be plus.
- Solid understanding of pharmaceutical clinical development process and rich experience of trial conduct, management.
- Good knowledge of applicable clinical research regulatory requirements; such as from FDA, ICH etc.
- Ability to independently formulate clinical development strategy for innovative drugs;
- Ability to lead a team to implement clinical development plans and solve problems;
- Familiar with domestic and foreign registration regulations, have extensive resources in the international pharmaceutical industry, and have strategic thinking and efficient execution.