Senior Director/Executive Director, Clinical Science

工作内容
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.