Non-Clinical Senior Manager
Associate Director of Non-Clinical
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.
- 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.
- 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.