Associate Director/Director, Clinical Operations – APAC

About the role

Based in Hong Kong, the Associate Director/Director, Clinical Operations will lead clinical operations across the Asia‑Pacific region, overseeing the planning and execution of the APAC trial portfolio. The role serves as the operational bridge between U.S., Greater China and APAC teams, ensuring timelines, budgets and quality standards are met.

Key responsibilities

• Provide regional leadership for study start‑up, execution and close‑out across multiple APAC countries, managing budgets, timelines and resources.
• Oversee CRO, central laboratory and vendor selection, ensuring compliance with ICH‑GCP and local regulatory requirements.
• Drive site selection, activation and enrollment, building relationships with investigators and hospital networks.
• Collaborate with global functional teams (regulatory, QA, biometrics, pharmacovigilance) and act as the primary operational liaison with China‑based partners.

Required profile

• Bachelor’s degree in life sciences (advanced degree preferred) with 8+ years (Associate Director) or 10+ years (Director) of clinical operations experience, including Phase 1/2 trials.
• Proven experience managing multi‑country trials in the Asia‑Pacific region and overseeing CROs/vendors.
• Fluency in English; Mandarin proficiency strongly preferred; right to work in Hong Kong or eligibility for a visa.
• Willingness to travel 20–30% regionally and internationally.

Required skills

• ICH‑GCP knowledge and APAC regulatory frameworks (HK, NMPA, FDA, TGA, MFDS, PMDA, HSA).
• Clinical trial management systems (CTMS) and electronic trial master file (eTMF) expertise.
• Study start‑up processes, including regulatory submissions and ethics approvals.
• Vendor oversight and budget management.

What we offer

• Regional ownership of clinical operations with opportunity to build and lead a growing team.
• Direct exposure to U.S. leadership and Greater China development partners.
• Competitive base salary, performance bonus and equity participation.
• Hong Kong statutory benefits, medical coverage, generous annual leave and flexible hybrid working.