北京招聘

1. To provide medical and scientific expertise to the design, planning, initiation and completion of clinical trials (from phase1 to phase 4 studies); and develop key documents (e.g. protocol, report, etc) in collaboration with cross-functional team.
2. To be responsible for communication of key clinical assumptions, risks and mitigation strategies by study/project.
3. To leads and/or participates in clinical/medical advisory panels, steering committees and investigator meetings.
4. To provide medical input into ongoing clinical studies：To perform medical monitoring for the projects; To manage and communicate with investigators; To support training and other scientific support for clinical operation and relevant third parties.
5. To provides input to publication strategy for the projects/products. May work with academic investigators to present and publish clinical trial results at scientific meetings and in peer reviewed medical journals.
6. To provide medical support to deliver regulatory submissions (IND and NDA, etc).
7. Relevant medical document preparation.
8. Communication with regulatory agency and relevant material preparation.
9. To provide medical and scientific input for other company business, e.g. business development.

Qualifications:

1. With hospital physician experience to take care of patients.
2. Minimum master’s degree in clinical medicine or related bioscience.
3. Prior experience (2-5 years) working in the pharmaceutical and/or biotechnology industry with a superb track record of accomplishments.
4. Ability to provide an oversight on clinical design, generation of protocols, case record forms and clinical study reports.
5. Understanding of requirements for successful development, registration and commercialization of a new product.
6. Knowledgeable in drug development process and the competitive environment.
7. Strategic thinking, strong problem-solving skills for developing creative solutions and contingency plans and meeting project objectives.
8. Strong oral and written communications skills in both Chinese and English.
9. Presentation skill.