岗位职责： 1. Clinical Study Design and Scientific Leadership  Lead the scientific design of clinical research programs, including the development, optimization, and review of clinical trial protocols.  Define study objectives, endpoints, inclusion/exclusion criteria, assessment schedules, and other critical study components.  Ensure clinical trial designs are scientifically sound, operationally feasible, and compliant with applicable regulatory requirements and industry standards. 2. Clinical Study Execution and Cross-Functional Coordination  Oversee the execution of clinical research projects throughout the study lifecycle.  Manage external partners, including Contract Research Organizations (CROs),investigational sites, and Ethics Committees/Institutional Review Boards (IRBs).  Collaborate closely with internal functions such as R&D, Regulatory Affairs, Quality, Biostatistics, and Data Management to ensure timely study initiation, conduct, monitoring, and close-out.  Ensure clinical studies are delivered on schedule, within scope, and in compliance with applicable regulations and Good Clinical Practice (GCP). 3. Clinical Data Analysis and Regulatory Support  Lead the scientific review, analysis, and interpretation of clinical study data.  Coordinate the preparation and review of Clinical Study Reports (CSRs) and other key clinical documents.  Provide clinical data support for regulatory submissions, including INDs, NDAs, and global registration activities.  Monitor and evaluate safety data throughout clinical development, ensuring timely identification, assessment, and management of adverse events and patient safety risks. 4. Clinical Development Strategy  Develop and implement clinical science strategies aligned with therapeutic area trends, unmet medical needs, and the company's portfolio strategy.  Evaluate emerging scientific evidence, competitive landscape, and clinical development opportunities.  Provide recommendations to optimize clinical development plans and enhance product differentiation and commercial value. 5. Team Leadership and Talent Development  Build, lead, and develop a high-performing Clinical Science team.  Oversee recruitment, performance management, coaching, and career development of team members.  Provide scientific guidance and mentorship to Clinical Scientists and other clinical development personnel.  Foster a culture of scientific excellence, collaboration, accountability, and continuous learning. 6. Compliance, Governance, and Strategic Planning  Monitor evolving global clinical research regulations, guidelines, and industry best practices to ensure ongoing compliance.  Contribute to corporate R&D strategy, portfolio planning, and clinical development budgeting.  Provide regular updates and strategic recommendations to senior management regarding clinical development programs and clinical science initiatives. Qualifications Education  Master's degree or above in Clinical Medicine, Pharmacology, Pharmacy, Life Sciences, or a related discipline.  Medical degree (MD) and/or physician licensure preferred.  International clinical development or global clinical trial experience is highly desirable. Experience  Minimum of 8 years of experience in clinical research and drug development within thepharmaceutical, biotechnology, or CRO industry.  At least 3 years of people management experience in Clinical Science or Clinical Development.  Demonstrated leadership or significant contribution to at least two drug development programs (small molecules and/or biologics) across Phase I–III clinical studies.  Thorough understanding of the full clinical development lifecycle and clinical trial processes. Technical Competencies  Deep expertise in clinical trial design, protocol development, clinical data interpretation, and scientific report writing.  Strong foundation in clinical pharmacology and clinical medicine.  Extensive knowledge of global regulatory requirements and guidelines, including NMPA, FDA, EMA, ICH-GCP, and related regulations.  Ability to independently address complex scientific and clinical development challenges. Leadership & Interpersonal Skills  Excellent project management, communication, stakeholder management, and cross￾functional leadership skills.  Strong analytical thinking, problem-solving ability, and attention to detail.  Proven ability to work effectively in a fast-paced and dynamic environment.  High level of accountability, resilience, and execution excellence. Language Skills  Excellent written and verbal English communication skills.  Ability to review scientific literature, prepare clinical and regulatory documents in English, and collaborate effectively with global partners and stakeholders.