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Johnson & Johnson 职业机会

Sr Principal Scientist DMPK

上海, 中国
Pharmacokinetics


职位描述

Requisition ID: 1905729080W

Your responsibilities
• Serve as a NCS Asia Pacific management team member to conduct scientific and administrative responsibilities.
• Function as a DMPK project leader to support discovery and development projects; work closely with biology, chemistry and nonclinical safety team members to reach the site objectives, including providing scientific guidance and suggestions for the lead compound selection, and solving DMPK related issues, attending regulatory meetings as needed
• Be responsible for all DMPK and bioanalytical related tasks and issues, including setting goals, establishing and implementing proper procedures and processes, and ensuring a favorable outcome.
• Identify, evaluate, and monitor Asia pacific-based CROs to timely deliver DMPK data to support local drug discovery and development projects.
• Provide scientific guidance and advice to direct reports and CROs on preclinical and clinical bioanalysis to meet global and APAC clinical and non-clinical bioanalytical needs.
• Assure all applicable Good Laboratory Practice regulations (CFDA/FDA/OECD) are followed as appropriate in the CROs, and ensure all raw data, documentation, protocols, specimens, and final reports are recorded and archived to meet Johnson and Johnson requirements.


资历
Your qualifications:
• Industry experience in ADME & PK and a proven track record of scientific achievement & project influence
• Extensive experience in drug discovery and development and familiar with global regulatory requirements (e.g. GLP, GCP, etc.) and submissions of IND, NDA, EMEA, and China CTA
• Broad understanding of various DMPK relevant areas such as physicochemical properties, drug metabolizing enzyme & transporter kinetics, pharmacokinetics, mechanistic biotransformation, analytical sciences is highly preferred.
• Ability to translate data into project relevance as part of anticipating and/or mitigating project challenges.
• General understanding of PK/PD modeling and its application to advance projects.
• Proficiency in human PK predictions.
• General understanding of drug discovery, medicinal chemistry and pharmacology/biology is preferred.
• Demonstrate strong teamwork skills and able to clearly communicate your ideas within an international team setting in a matrix environment
• Good communication skills in both verbal & written Chinese and English.


主要地点
中国-上海-上海-
组织
强生(中国)投资有限公司
工作
Pharmacokinetics
Requisition ID
1905729080W