Key responsibilities:
- Assess non-clinical drug efficacy, mode of action, pharmacology and pharmacokinetics studies and ensure adherence to regulatory guidelines.
- Stay updated with evolving regulatory requirements and ensure that studies meet regulatory standards.
- Communicate with regulatory authorities, and convey, adapt, and influence internal stakeholders on non-clinical pharmacological issues.
- Review of the non-clinical pharmacologic reports by external partners includes evaluation of the quality and adequacy of the various assessments (pharmacology, safety pharmacology, etc).
- Provide expert scientific support in the areas of non-clinical pharmacology, DMPK to project teams, and ensure non-clinical packages to support clinical development.
- Facilitate project transitions to clinical development in close collaboration with discovery, translational and clinical scientists.
Qualifications
Required:
- PhD in pharmacology, or an area relevant to non-clinical pharmacology
- 5-10+ yrs of industry and research experience in drug development.
- Hands-on experience in non-clinical pharmacology, PK/PD/Immunogenicity, and drug development in multiple therapeutic areas.
- Extensive experience in developing the strategy & designing, directing & implementing non-clinical pharmacology plans for multiple compounds, both biologics and small molecules.
- Knowledge of the current practices and issues in the non-clinical pharmacology, nonclinical metabolism and pharmacokinetics, and safety pharmacology areas
- Technical and practical knowledge of non-clinical pharmacology related global and China regulatory guidance and experience successfully delivering regulatory documents (reports, INDs, briefing documents, etc).
- Demonstrated strong written and verbal communication skills - the ability to clearly and persuasively articulate complex concepts and strategies to a diverse audience.
Preferred:
- Record of publishing in high profile scientific journals.