1. The Head of Clinical Pharmacology 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, QT/QTc, DDI and leadership in the related studies and performs modeling and simulation analysis using nonclinical and/or clinical data to guide dose regimen for pivotal studies;
4. Be responsible for the development of a competitive clinical pharmacology medical part of the label which allows an optimal positioning of the drug in the market;
5. 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;
6. 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 and works with non-clinical and operational team members for assay development, sample management, PGx and biomarker development to design and execution of FIH studies;
7. Be responsible for the ongoing benefit/risk assessment of assigned drug candidates and that relevant actions and decisions;
8. Manage clinical pharmacology activities related to budget planning, vendor identification, outsourcing of PK, PK/PD analyses, and contract requisition;
9. 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.
1．A PhD, PharmD or MD equivalent degree in Clinical Pharmacology, Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering or related quantitative discipline with significant modeling-related content and 10+ years relevant work experience in clinical drug development;
2．Excellent knowledge of phase I-3 clinical 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;
3．Excellent experience with quantitative approaches, modeling and simulation in drug development, and working knowledge of relevant modeling software such as NONMEM, WinNonlin, R, SimCYP, and GastroPlus is desired;
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．Strong track record of publications and able to apply scientific knowledge to the company's products, identify issues, apply insightful analysis, and solve problems effectively;
8．Strong consulting skills in the drug development context within internal function teams, external experts and working experience interacting with regulatory agencies; 9．Excellent presentation skills to a wide range of target audiences, including, but not limited to cross-functional teams, academic conferences and with regulatory meetings;
10．Capability to lead across diverse cultures with flexibility to work with global teams in different time zones;
11．Fluent in English (oral and written) is desired.
1. Responsible for medical evaluation of clinical trials and post-marketing drug ICSRs；
2. Responsible for writing or reviewing drug safety parts of documents such as IB, clinical trial protocol, ICF, clinical study report /summary, clinical study safety data review and summary；
3. Responsible for drug safety signal detection, evaluation and management, including drug benefit-risk evaluation；
4. Responsible for Chairing the product safety management committee for safety identification, assessing if IB/RMP update required and if any actions to be taken；
5. Responsible for writing the Risk Management Plan and review relevant documents for IND and NDA submission；
6. Provide pharmacovigilance training and coaching for new employees；
7. Responsible for the pharmacovigilance annual summary report；
8. Responsible for writing PSUR/DSUR, etc. ；
9. Responsible for the communication of drug safety information, such as initiating company drug safety committee meetings；
10. Writing relevant PV system documents, such as SOP and WI；
11. Support the convening of the safety audit committee；
12. Complete other works and tasks assigned by the PV head and company upper managers in time.
1、Bachelor degree or above in medicine related majors;
2、8 years or above medical work experience in medical industries; 8 years or above PV related work experience; 5 years or above PV Physician experience;
3、Familiar with industry laws and regulations, and the ability to interpret in-depth regulations;
4、Good English oral communication skills;
5、Have certain experience GVP and or GCP audits;
6、Familiar with the operation of pharmacovigilance database systems (eg Argus, Arisg);
7、Excellent communication, coordination, execution and management skills.
