1. The Senior Clinical Pharmacologist is responsible for leading design, execution, review, interpretation and reporting of all clinical pharmacology activities related to clinical studies and regulatory submissions (NMPA, FDA, etc.) and driving the clinical pharmacology strategies in clinical development ensuring progression through key development milestones beyond market authorization and in Life-Cycle-Management.

2. Leads or contributes to preparation of submission documents, health authority and ethics committee meetings which include, but are not limited to development of clinical pharmacology sections for protocol development, study execution, reporting, data analysis, regulatory filings including annual reports, IB, and IND/NDA submissions.

3. Provides medical expertise to key components of clinical pharmacology in drug development such as dose finding, dose schedule, PK/PD, ER, and leadership in the related studies.

4. Applies the interpretation of the impact of concomitant medication use, PK/PD data, and requirements for the clinical pharmacology regulatory submission packages, publications and external presentations.

5. Leading development and implementation of the clinical pharmacology strategy in order to ensure that the right drug is administered to the right patient at the right dosing regimen.

6. Be responsible for the ongoing benefit/risk assessment of assigned drug candidates and that relevant actions and decisions.

7. Works on cross-functional teams in close partnership with the medical, operational, project, regulatory, biostatistics, PV, translational, CMC, BD and other function leaders in support of the drug development according to the company strategies, timelines and milestones.

8. Manage clinical pharmacology activities related to budget planning, vendor identification, outsourcing of PK, PK/PD analyses, and contract requisition.

Qualifications：

1.A Master, PhD, PharmD or MD equivalent degree in Clinical Pharmacology, Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering or related quantitative discipline.

2. 5 years relevant work experience in clinical drug development.

3.Knowledge of clinical study design, operation, drug development, global study regulatory requirements and PK/PD analysis and industry experience in applications of basic research and translational medicine in clinical design and execution.

4. Knowledge of the latest developments in clinical pharmacology, proof-of-concept investigation and guidance documents and evidence of hands-on experience in the application of pharmacometrics methods to drug development.

5. Strong ability to perform PK/PD data analyses, interpret clinical data and their relation to the clinical setting and able to handle multiple clinical pharmacology programs simultaneously.

6. Drug development experience in one or more therapeutic areas with working knowledge of clinical and regulatory landscape, patient populations, disease mechanisms, treatment paradigms, and competitive landscapes.

7. Able to apply scientific knowledge to the company's products, identify issues, apply insightful analysis, and solve problems effectively.

8. Working experience interacting with regulatory agencies.

9. Flexibility to work with global teams in different time zones.

10. Experience with quantitative approaches, modeling and simulation in drug development is desired.

11.Fluent in English (oral and written) is desired.