职位详情
Principle Preclinical Scientist
4-5万
西安万兴服务外包有限责任公司
上海
5-10年
硕士
07-30
工作地址

新研大厦1

职位描述
JOB SUMMARY

The individual will serve as a (key) scientific contributor for the development and execution of preclinical strategy. The individual will contribute to/independently complete the design, execution, analysis and interpretation of preclinical studies to understand the safety and efficacy of products.

DUTIES & RESPONSIBILITIES

Under limited supervision and in accordance with all applicable China and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

Liaison with Business Partners

Provides preclinical scientific input on and assist to develop preclinical strategy as needed.

Communicates progress and milestone status to key stakeholders.

Preclinical Sponsor Oversight

Provides input and reviews for study protocols and reports from external preclinical studies.

Oversight of the study implemented in external labs to ensure compliance, scientific soundness, and integrity of the study.

Preclinical Study Execution

Planning and executing preclinical animal studies as needed.

Responsible for design of preclinical animal studies as needed.

Performs the role as designated Study Director as needed.

Responsible for ensuring compliance with all country, local and Company regulations, policies, and procedure.

Performs other duties assigned as needed

Requirements:

Doctorate degree preferred in veterinary medicine, medical, biological sciences, biomedical engineering, and related major. Master’s degree required. At minimum 3 years of experience in preclinical research experience in a medical device or pharmaceutical setting. GLP background is preferred.

Experience with large animal preclinical studies as study director is preferred.

General knowledge of Preclinical Research is required. Knowledge of NMPA regulations related to preclinical research is highly desired.

General knowledge of animal and human anatomy and physiology, surgical principles & theory, as well as biological systems is highly desired.

Skills to develop tactics to successfully complete programs/projects/studies is required including trouble shooting skills.

Able to articulate scientific basis for decisions to project team partners.

Good communication skills to facilitate smoothly work cross functionally.

Good English communication (both written and verbal) skill is required.

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