Primary Responsibilities：

1、Contribute to clinical development strategies and develop trial protocol for phase 1~3 based on regulatory requirement and business needs to generate clinical data for new product approval and strengthen product life cycle management

2、Take medical responsibility in clinical trial execution with high scientific and ethical standards to ensure the quality of clinical trial for regulatory submission and promotion use

3、Generate key clinical documents and interact with Health Authority to achieve timely CTA/NDA submission and approval

4、Build up relationship with KOLs/Investigators to influence them to accommodate and overcome medical or treatment procedure barriers in clinical programs to facilitate trial execution and advocate company’s products

5、Provide medical expertise in protocol review within relevant filed to contribute global development

6、Be medical representative in routine communication with Health authority

7、Coach medical scientists regarding the general and professional competencies, skills and knowledge in order for them to accomplish their accountabilities

Qualifications：

1、3-5 years of clinical development experience (at least as clinical research physician for 3 years) in global pharmaceutical

2、Pharmaceutical experience in NDAs, preparing for Authority Meetings in the therapeutic areas, Phase 1-3 best practices and procedures, Standard Operating Procedure development, and working with CROs/vendor

3、Excellent communication and presentation skills

4、Work independently within expertise

5、Excellent collaboration in a cross functional team setting

6、Ability to quickly adjust to new situations in project management

7、Proficiency in both written & spoken English

8、Master degree or above in clinical medicine

其他信息


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