Medical Director

Key Responsibilities l Clinical Development & Medical Execution: Lead the medical oversight and launch of CSTI-500’s Phase 2 study for Fragile X Syndrome (FXS) in Hong Kong/China, including post-FDA/NMPA approval activities (CRO medical operations guidance, site selection, investigator initiation meetings). Collaborate with the US team to align medical standards for the PWS Phase 2 trial, ensuring consistency in study protocols, safety monitoring, and data interpretation. Meanwhile, provide hands-on medical expertise for all CSTI-500 Phase 2 programs, leading protocol development, endpoint selection, inclusion/exclusion criteria refinement, dose-escalation rationale, and safety monitoring plan design to guarantee scientific rigor and regulatory compliance. l Clinical Documentation & Compliance Oversight: Oversee clinical study documentation (protocol amendments, investigator brochures, adverse event reports) from a medical perspective, ensuring compliance with ICH-GCP, Hong Kong DH regulations, and GBA/China clinical practice standards. Implement and maintain medical quality management systems throughout the study life-cycle; conduct regular progress reviews, assess medical risks, and propose mitigation plans to keep programs on track. l Clinical Execution & Safety Oversight: Review adverse events (AEs/SAEs) and protocol deviations, collaborating with CROs, external medical monitors, and cross-functional teams to analyze emerging safety data. Serve as the primary medical point of contact for investigational sites and CROs on protocol and safety-related queries, ensuring consistent medical decision-making across regions. l Regulatory & Stakeholder Engagement: Liaise with Hong Kong DH, GBA hospitals, ethics committees, and global regulatory bodies (e.g., NMPA for IND interactions) to facilitate trial setup, execution, and regulatory submissions by providing clear medical rationale. Engage with CNS field KOLs to gather clinical insights and support trial advancement. l Early-Stage R&D Support & Cross-Functional Collaboration: Provide medical and clinical input for early-stage rare CNS R&D projects, supporting preclinical-to-clinical translation, indication selection, and initial clinical strategy development. Collaborate closely with Clinical Program Management, CNS Translational Science, Pharmacology, /PD, and Safety teams to integrate medical insights into the overall development strategy, maintaining globally aligned clinical development standards across U.S. and Hong Kong teams. Requirements & Qualifications l Education: Medical degree (MD, MBBS, or equivalent) is mandatory. Clinical training in psychiatry, pediatrics, neurology, internal medicine, or a related specialty is preferred. Eligibility for medical registration in Hong Kong (e.g., HKAM) or other major jurisdictions is a strong plus. l Experience: Minimum 3 years of post-training experience, including clinical research or biotech/pharmaceutical industry exposure. Prior involvement in clinical trials (Phase 1–2), particularly in CNS disorders, rare diseases (e.g., PWS or FXS), is strongly preferred. Experience leading medical oversight of cross-regional clinical programs (e.g., U.S.–Asia collaboration) is a critical advantage. l Technical Expertise: Solid understanding of clinical trial design, medical monitoring, and early-stage clinical development processes for CNS therapeutics. Deep familiarity with ICH-GCP guidelines, global regulatory expectations, and Hong Kong/China regulatory requirements (e.g., CTA application, GBA clinical trial filing). Experience supporting regulatory submissions or interacting with regulatory agencies (directly or indirectly) is preferred. l Skills: Excellent verbal and written communication skills in English (mandatory); proficiency in Chinese (Cantonese/Mandarin) is preferred for regional stakeholder engagement. Strong analytical thinking, problem-solving, and collaboration skills. Ability to thrive in a lean, fast-paced startup environment with evolving priorities. Familiar with or willing to learn AI-enabled tools (e.g., clinical data analytics platforms, trial design optimization software, safety monitoring tools) to enhance clinical trial efficiency, data accuracy, and cross-regional coordination.