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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