Main Responsibilities:
1.Contribute to clinical trial documentation development, including but not limited to clinical study protocol (synopsis), clinical study report, trial disclosure form, publication, etc.
2.Provide medical evaluation and support in early assessment, work out (as one of the key member) drug development strategy and clinical development plan.
3.Contribute to pre-IND/IND package preparation, application and communication with health authorities.
4.Take medical lead in clinical study implementation, and perform medical monitoring to ensure patients’ safety.
5.Contribute to NDA/BLA strategy, package preparation, submission and related communication with Health Authorities
6.Conduct KOL mapping and effectively communicate with KOL to maintain solid scientific relationship, understand Chinese clinical practice and clinical requirements.
7.Lead product life cycle management and new indications extension
8.Provide strategic support to products and company development, including but not limited to external collaboration.

Skill Requirements:
1.Doctor’s degree in Medicine with specialty training, or above
2.Over 10 years of experience in pharmaceutical industry environment, experience of new product launch of Metabolic disease is preferred.
3.Well established TA medical knowledge and well-understood to regulatory guidance for ICH/GCP
4.Experience of clinical study design, medical monitoring, CSR authoring, new drug early assessment, health authority communication is preferred
5.Academic network in related TA is a plus
6.Well-developed of time management skill and ability to determine and prioritize workload
7.Well-developed of other soft skill including but not limited to presentation, analytical and interpersonal skills
8.Strong business acumen, master of business administration is a plus.

其他信息
语言要求：英语、普通话