Clinical Operation Director
- 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 Director of Clinical Operation is to be responsible for developing the operation 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.
- Lead the trial operational strategy, plan and executions of assigned clinical projects in the United States or other countries, cooperate with Chinese clinical teams to drive multicenter clinical trials around the world, when necessary, establish goals and measures progress toward critical trial milestones.
- Ensures that projects are properly resourced, managed and executed within budget and in accordance with established timelines and quality standards.
- Responsible for selecting and monitoring clinical trial sites and CRO vendor to ensure performance and provide guidance as needed.
- Controls the overall process and results of clinical project timeline and quality.
- Lead the development and management of clinical trial documentation to meet the requirements of ICH- GCP, SOP and local laws and regulations.
- Maintains good communications with Sites and PIs, travel to sites monitor project milestones when necessary.
- Proactively identify potential clinical operation risks, propose risk mitigation options and generate contingency plans when necessary.
- Provide strategic advice, clinical guidance, and status reports to senior management, other functions and partners, as appropriate.
- Actively monitor current and emerging clinical trial relevant policies/ practices, and assess the impact on company’s development programs.
- Conduct clinical operation due diligence for potential and new BD&L projects and advise management.
- Setup and maintain Quality Management System with regards to the clinical operation process (e.g., Development/review clinical SOPs); Prepare and participate in audits/inspections (internal/external audits, supplier and document audits) when needed.
- Provide cross-functional support (e.g., RA, Clinical Development) with trial relevant expertise when necessary.
Required Education, Experience, Skills & Competencies
- Bachelor’s degree (advanced degree preferred) in a life science field (e.g., Medicine, Biology, Pharmaceutical sciences)
- 10 + 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 and monitoring.
- Proven ability to manage budgets, resource and projects.
- Good knowledge of applicable clinical research regulatory requirements; such as from FDA, ICH etc.
- Strong written and oral communication skills; proven ability to work effectively with cross-functional teams, as well as influence diverse internal and external stakeholders.
- Leadership skills and ability to interact with senior management, and to work with outside vendors and partner companies.
- Demonstrated self-starter and hands-on player.