上海招聘

Major Responsibilities and Duties:

1. Maintain a current understanding of pharmacology and toxicology literature and methodology. Get understanding of the latest status of competitors in the market to guide target product development.
2. Design and manage non-clinical studies (GLP and non-GLP) for inclusion in regulatory submissions following regulatory requirements, including pharmacology, pharmacokinetics and toxicology.
3. Work closely with the discovery group for therapeutic candidate selection.
4. Collaborate with CMC team to ensure coordination of manufacturing activities and support for toxicology and pharmacology studies with compliance with regulatory requirements.
5. Ensure bioanalytical and immunogenicity analysis method development/validation in collaboration with in-house and external bioanalytic professionals, and facility smooth technical transfer from non-clinical to clinical developments.
6. Oversees CROs in the design, conduct, analysis and interpretation of pharmacology and toxicology studies, and conduct on-site inspection for documentation and data retention to ensure that studies are delivered within agreed quality, cost and timeline parameters.
7. Review non-clinical study reports to ensure accurate reflection of study data and scientific interpretation of study results.
8. Prepare and edit non-clinical documents for regulatory submission.
9. Write position papers on safety, pharmacology and mode of action to support product development.
10. The incumbent will report directly to the Head of Non-Clinical Development.
11. Other work for request.

Qualifications:

1. M.S. or Ph.D. in Medicine, Biological Sciences, Toxicology, Pharmacology.
2. Minimum 3 years working experience in non-clinical drug development area.
3. Proven experience in design, coordination, analysis and documentation of non-clinical studies Independently.
4. Ability to synthesize and interpret diverse, multidisciplinary data sets.
5. Excellent scientific writing and editing as well as written/oral communication skills with several years of professional experience in scientific writing.
6. The ability to work independently and to collaborate with a multi-disciplined group in a goal- and team- oriented setting is required.
7. Highly flexible, results oriented, independent self-starter and team player who enjoys working in a fast-paced dynamic environment.