Medical Director – Clinical Development & Regulatory Oversight

About the role

The Medical Director will lead clinical development and medical oversight for a Phase 2 program targeting Fragile X Syndrome in Hong Kong/China, while supporting parallel CNS rare‑disease projects across the organization.

Key responsibilities

• Direct medical strategy for the CSTI‑500 Phase 2 trial, including site selection, investigator initiation, and post‑approval activities.
• Collaborate with U.S. teams to harmonise medical standards for the PWS Phase 2 trial, ensuring consistent protocols, safety monitoring and data interpretation.
• Oversee clinical documentation (protocol amendments, investigator brochures, AE reports) and ensure compliance with ICH‑GCP, Hong Kong DH and Chinese regulations.
• Review adverse events and protocol deviations, acting as the primary medical contact for sites and CROs.
• Liaise with Hong Kong DH, GBA hospitals, ethics committees and global regulators (e.g., NMPA) to facilitate trial setup and submissions.
• Provide medical input for early‑stage rare CNS R&D, supporting pre‑clinical to clinical translation and indication selection.

Required profile

• Medical degree (MD, MBBS or equivalent) – mandatory.
• Clinical training in psychiatry, pediatrics, neurology, internal medicine or related specialty – preferred.
• Eligibility for medical registration in Hong Kong or another major jurisdiction – strong plus.
• Minimum 3 years post‑training experience, including clinical research or biotech/pharma exposure.

Required skills