Associate Director, Clinical Operations

The Associate Director, Clinical Operations serves as leadership role within the Clinical Operations department under the supervision of Senior Director, Clinical Operations, is responsible for the execution planning and conduct of clinical trials. This requires deep operational expertise to ensure trials are conducted in compliance with regulatory and ethical requirements, timelines, and budgetary constraints, and of the quality required to support submission to relevant authorities for drug approval.

• Conduct end-to-end clinical trial management (start-up through close-out), ensuring adherence to GCP, SOPs, and regulatory standards.
• Lead early feasibility efforts and country/site selection
• Develop clinical trial/program budgets and liaise with Finance/Accounting in communicating budget forecasting and accruals
• Develop timelines for assigned clinical trials and programs 
• Develop Request for Proposals (RFPs) and define scope of services for outsourced clinical activities
• Identify and escalate project risks; assist in developing mitigation strategies.
• Monitor performance of CROs, vendors, and investigative sites to ensure trial quality and data integrity.
• Partner with Clinical Development, Medical Affairs, Data Management, and other functions to optimize study design and execution plans.
• Contribute to the clinical content of Investigator’s Brochure (IB), Development Safety Update Report (DSUR), etc.
• Partner with CROs to inspire superior performance and develop long-term partnerships to the mutual benefit of company and our service partners
• Interact and establish relationships with clinical trial investigators and key opinion leaders

• BS/BA required, advanced degree (MSc, PhD, PharmD, or MD) in life sciences, medicine, or related field preferred.
• 10+ years of clinical operations experience (biotech/pharma/CRO), including at least 4+ years clinical study management experience. Prior exposure to global trial experience, e.g.. manage project in other countries rather than China.
• Hands-on experience managing clinical trial processes and overseeing CROs/vendors.
• Prior exposure to regulatory submissions (e.g., IND, NDA) or inspections is a plus.
• Strong project management skills with ability to drive complex tasks independently.
• In-depth knowledge of ICH-GCP, FDA/EMA regulations, and clinical trial operations.
• Fluent in both spoken and written English communication.