Non-Clinical Sr. Manager

Department
部门

Non-Clinical

Title
职位

Non-Clinical Senior Manager

Starting Date
任职时间

–

Direct Report
直线经理

Associate Director of Non-Clinical

Direct Subordinates
直接下属
N/A
Primary Function
主要职能

In charge of non-clinical development activities (PD/PK and safety) for regulatory submission of new products; facilitate and execute non-clinical studies for candidate selection and development in the product pipeline.

Major Responsibilities and Duties
主要职责和任务
  • Maintain a current understanding of PK, PD and toxicology literature and methodology. Get understanding of the latest status of competitors in the market to guide candidate product development.
  • Design and manage non-clinical studies for inclusion in regulatory submissions following latest regulatory requirements, including pharmacology, pharmacokinetics and toxicology.
  • Oversee CROs in the design, conduct, analysis, trouble shooting, documentation and data retention, and interpretation of nonclinical studies, and conduct on-site inspections to ensure that studies are delivered within agreed quality, cost and timeline parameters.
  • Review nonclinical study reports to ensure accurate reflection of study data and scientific interpretation of study results.
  • Prepare and edit nonclinical documents for regulatory submission and regular updates for life-cycle management.
  • Work closely with other functions to support the candidate selection, CMC process changes, clinical protocol development, annual report and RA submissions.
  • Other work as requested.
Qualifications
资格要求
  • M.S. scientist with 3+ years or Ph.D. scientist with 1+ years of industry experience. Background in immunology, toxicology, pathology, pharmacokinetics, pharmacology, oncology or related fields.
  • Familiar with regulatory guidelines or experience in IND-enabling studies.
  • Experience as a pathologist, pharmacokinetics or study director of toxicological studies would be a plus.
  • Literature and database retrieval ability and excellent written and verbal communication skills in both Chinese and English are required.
  • Proven capability in independent trouble-shooting.
  • Highly flexible, and team player who enjoys working in a fast-paced dynamic environment.