Oversee end-to-end execution of Phase IIII global multicentre trials (MRCTs) across regions including the China, US, Europe, .
Manage regional clinical operations teams and ensure trial quality, timelines, and compliance with CFDI, FDA, EMA, and ICH-GCP standards.
Serve as the primary point for regulatory inspection readiness (CFDI/FDA/EMA) and response.
Build and maintain strategic relationships with KOLs, clinical sites, and CROs in key regions, especially the US and Europe.
Collaborate with global cross-functional teams to align regional execution with worldwide development strategy.
Qualifications:
Master's degree or higher in Clinical Medicine, Pharmacy, Biology, or a related field.
13+ years of clinical operations experience, including at least 8 years focused on clinical trial management , with experience in pharmaceutical or biotechnology companies.
Proven experience in managing full-cycle Phase I-III global clinical trials, including hands-on experience in international MRCT project management, and having led at least one project from initiation through regulatory submission.
Experience in designing and executing Non-Oncology Phase III clinical trials, with familiarity with clinical development pathways and regulatory requirements in relevant therapeutic areas.
Understanding of the local clinical research environment, site operations, and healthcare policy/regulatory landscape.
Strong leadership skills with the ability to effectively manage local teams and collaborate across cultures and time zones.
Fluent in both English and Chinese, with proficiency in using both as working languages, and capable of cross-cultural communication and coordination.
