Position Title
Clinical Operations Director
Location
United States， Global responsibility covering US, Australia and other sites out of China
Reporting Line
Global Clinical Operations VP
Company Overview
Our client is a clinical-stage biotechnology company focused on the development of first-in-class and best-in-class cardiovascular and metabolic innovative therapies, leveraging proprietary drug delivery and translational platforms.
The company is preparing for HK IPO, with active multi-regional clinical trials in China, the US, and Australia.
Position Summary
The Clinical Operations Director will provide strategic and operational leadership for company’s global clinical development programs, with primary responsibility for end-to-end execution of multi-regional clinical trials in the responsible sites.
This role will build and lead the global clinical operations function, ensure regulatory-compliant, high-quality, and efficient trial delivery, and serve as a key bridge between global headquarters in China and overseas clinical teams, CROs, and investigators.
Key Responsibilities
Global Clinical Operations Leadership
Lead the global clinical operations strategy and execution across all development stages (Phase I–III), with an initial focus on cardiovascular indications.
Oversee multi-regional clinical trials (MRCTs), ensuring alignment with global development plans and regulatory expectations.
Build scalable clinical operations capabilities to support pipeline expansion and late-stage development.
Trial Execution & Oversight
Ensure on-time, on-budget, and high-quality delivery of global clinical trials.
Provide oversight of study start-up, site selection, enrollment, monitoring, data quality, and trial close-out.
Identify and mitigate operational risks, proactively addressing enrollment, site performance, and vendor issues.
CRO & Vendor Management
Select, manage, and govern global and regional CROs, central labs, imaging vendors, and other service providers.
Establish clear performance metrics, KPIs, and governance models to ensure accountability and execution excellence.
Cross-Functional & Global Collaboration
Partner closely with Clinical Development, Medical Affairs, Regulatory Affairs, Biometrics, CMC, and Project Management teams globally.
Act as a key interface between US-based teams and China headquarters, ensuring clear communication, cultural alignment, and decision efficiency.
Compliance & Quality
Ensure all clinical activities comply with ICH-GCP, FDA, NMPA, TGA, and other relevant regulatory requirements.
Support regulatory interactions, inspections, and audits related to clinical operations.
Team Building & Leadership
Recruit, develop, and lead a high-performing global clinical operations team, including internal staff and functional leads.
Foster a culture of execution excellence, accountability, and collaboration across regions.
