1. With experience managing data, writing and reviewing clinical pharmacology/PK reports and regulatory
submissions dossier and responding to regulatory queries.
2. Conducts clinical pharmacology studies in line with product development strategies, regulatory
requirement and scientifically sensible; Collaborate with the investigator sites, investigators, CRO or other
Partners and ensure high quality standards of their deliverables.
3. Serves as clinical pharmacology expert in the assigned project team; leads the study design and
coordinates pharmacokinetic / DMPK related elements for projects.
4. Manage PKPD analysis for understanding of PKPD relationship for drug effect and dose selection.
5. Oversees PK, PK/PD and DMPK biopharmaceutical analyses performed with a variety of tools and
6. Identify potential risks and provide mitigation strategies from DMPK perspective.
7. Review and ensure PK or PD analysis plan and report in phase I, II and III .
8. Representing the clinical pharmacology during the Communication with HA.
9. Assists with managing timelines and budgets to ensure efficient execution of clinical pharmacology
1. Advanced training with a degree of Master, PhD, PharmD or MD.
2. 5-8 year's industry experience with investigation of drug metabolism, transporters, and biotransformations of therapeutics.
3. Knowledge of bioanalytical expertise, PK, metabolism, drug interactions, and regulatory requirements.