南京招聘

Job Summary:
As a member of the Clinical Development within PDSP and Cell Therapy BU, this position is responsible for developing and implementing clinical research/development plan of new cell therapy products in oncology and hematology. He or she will lead the planning, design, execution and reporting of clinical research and development activities at various stages to advance new cell therapy development while work with hospital clinical opinion leaders closely. Monitor the change and development of relevant government policies and guidelines regarding cell therapy.
Responsibilities:
? Lead the preparation of clinical research plans, clinical study protocols, clinical sections of INDs and CTAs, and other key documents including investigator brochure and clinical study reports
? Identify and select investigators and study sites for clinical study and manage external collaborations
? Work with key opinion leaders and clinical investigators to further development goals
? Lead clinical project teams in the implementation of approved clinical research and development plans and ensures that quality objectives and timelines are met
? Supervise clinical research and development activities and programs following China government policies, regulations and guidelines, ICH guidelines, GCP, regulatory requirements and SOPs.
? Interface with other functions and organizations within and outside Clinical Development to ensure proper design, preparation, execution and overall management of clinical trials
? Participate in interactions with regulatory agencies
? Represent the Clinical Science function in interactions with partners involved in co-development programs
? Other responsibilities and duties based on business needs
Qualifications:
? Clinical training and a medical degree are essential
? At least 3 years of clinical practice experience in hematology/oncology or a relevant specialty in China is required
? Cell therapy research experience is preferred
? At least 3 years of working experience in pharmaceutical, biotech, or CRO with proven proficiency in clinical research and clinical science for drug development is strongly preferred
? Experience and knowledge in oncology/hematology
? Good understanding of ICH guidelines, GCP and regulatory requirements
? Excellent planning, organization and problem solving abilities
? Excellent management, communication and interpersonal skills
? Proficiency in English (written and oral)
? Familiar with IT and office tools

药明康德是国际领先的开放式能力与技术平台公司，为全球制药及医疗器械等领域提供从药物发现、开发到市场化的全方位一体化的实验室研发和生产服务。本着以研究为首任，以客户为中心的宗旨，药明康德通过高性价比、高效率的服务平台帮助全球客户缩短药物及医疗器械研发周期、降低研发成本。药明康德平台涵括化学药研发和生产、细胞及基因疗法研发生产、药物研发和医疗器械测试等，正承载着来自全球30多个国家的3500多家创新合作伙伴的数千个研发创新项目，致力于将最新和***的医药和健康产品带给全球病患，实现“让天下没有难做的药，难治的病”的梦想。