医学顾问、专家、经理、总监
职位编号 B09130021
行业 制药/医疗
类型 制药/生物工程
所在地 Shanghai
职位描述:

1、Managing and moving forward for company’s clinical trial programs of NMEs, including phase I, phase II and phase III trials; 
2、Responsible for clinical protocol design and implementation, and for CRO’s management; 
3、Participating in preclinical IND program and providing clinical inputs on regulatory affairs.4) Providing progress reports to the senior management 。

职位要求:

1、Ideal candidate should hold a medical Doctor or Master degree or Ph.d degree in Medical related area like Medi-chem, Biology… from USA or European countries;
2、 Three (3) or more years of oncology clinical trial management experience Demonstrated ability as a medical expert in a complex matrix environment;
3、Clinical research experience in the biopharmaceutical industry (oversea biotech, pharmaceutical or big CRO company);
4、Familiarity with concepts of clinical research and clinical trial design, including biostatistics;  
5、Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and ability in applying the regulations and guidelines to  international regulatory requirements; 
6、Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication; 
7、Sound scientific and clinical judgment;  
8、Good problem-solving skills; 
9、Experience and skills in interacting with regulatory officials in SFDA;
10、Fluent in both Chinese and English。 

 

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