1. Leading roles in preclinical and early clinical studies, including but not limited to drug analysis in vitro and in vivo, and PK/TK support;

2. Lead cross-functional metabolic project teams (toxicology, pharmacology, clinical development, CMC, and others). Provide important feedback from the DMPK project team;

3. Lead the development of DMPK regulatory activities in Synth Pharmaceuticals, it helps to generate and review materials such as researcher's brochures, CTA, and Blas / MAA and all licensing activities to provide scientific support;

4. Manage cooperation and CRO / CMO outsourcing activities. Provisional and final deliverables in project schedules and budget requirements;

5,Guide experimental methods for the DMPK problem with other preclinical R & D senior staff ;

6. Contribute to departmental development, budgeting, and personnel development as a key member of the system's management team;

7. Responsible for ensuring all reported DMPK related reporting schedules. It is expected to review, edit, and provide critical feedback through CRO or subordinate generated reports.

1. This position should be proficient in theoretical knowledge of clinical pharmacology and pharmacokinetics technology, be able to formulate or participate in the formulation of development strategies, drug declaration strategies, etc., be able to participate in various drug research and development teams, and have the ability to evaluate project feasibility;

2. The design and implementation of BE, pharmacokinetics, pharmacodynamics and clinical trials can be performed in accordance with GCP requirements. While satisfying domestic and international requirements, ensure that the clinical trial design is reasonable and the data are true and accurate;

3. This position requires strong data management and statistical knowledge, as well as the ability to interpret the test results accurately and reasonably. It also requires a good grasp of relevant data processing software and an overall understanding of the drug development process.

4. Familiar with the preparation and submission of materials by international drug regulatory agencies;

5. Ability to establish reasonable project criteria with colleagues in different functional departments, supervise and promote project progress, and be able to communicate with management in a timely and effective manner;

6. Participate in the assessment of new drugs and determine the requirements of the project under consideration, including the assessment of clinical pharmacology and clinical efficacy data of potentially acquired foreign company products or collaboratively researched and developed related products, and participate in the design and implementation of the project's clinical strategy.

1. Designs and implements biochemical and cellular assays to guide the target validation primarily in the areas of oncology, immunology and neurosciences;

2. Leads the design and implementation of screening strategies for Hit Identification through either High Throughput Screening or other technologies;

3. Provides leadership in developing innovative approaches to screening and hit triage;

4. Ensures hits are pharmacologically relevant by applying necessary validation assays;

5. Analyzes validation and screening data including presentation at program team meetings;

6. Works with other leaders in non-clinical R&D to design mechanisms of action studies for drug candidates;

7. Responsible for grow internal talents and capabilities through recruiting and mentoring

This position will be a key member of the R&D team supporting multiple areas including toxicology, bioanalytical sciences, PKPD and clinical pharmacology. S/he may also be as a primary representative on program teams and in collaboration and interaction with other functions in across development programs.

1.Develop and implement nonclinical safety strategies, design toxicology studies, author regulatory documents.

2.As a member of an integrated project team, interact with internal and external partners, and as well as regulatory agencies.

3.Ensure high scientific standards in conducting and reporting of nonclinical safety and investigative toxicology studies, and working with research project teams to utilize and interpret animal models of diseases for efficacy assessment and PK/PD evaluation

4.Manage studies at CROs and monitor to ensure high quality deliverables of the safety studies.

5.Work with the senior management to manage the departmental budget and resource.

1. Effectively manages the drug safety function to ensure that safety reports received from clinical trials (and post-marketing) are processed and reported according to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures.

2. Provides medical expertise in the review and analysis of clinical study safety information.

3. Participates in the review of individual SAE reports, prepares medical commentary and analysis, and in the preparation of safety evaluations in aggregate periodic reports.

4. Ensures accurate medical coding (MedDRA and WHO-DD) of safety data.

5. Represents the Pharmacovigilance & Drug Safety department in safety-related discussions with clinical investigators, IRBs/ECs, Data Monitoring Committees and regulatory authorities.

6. Protects study subject safety by contributing to the ongoing risk/benefit analysis of investigational drugs in clinical development.

7. Prepares and maintains departmental policies and SOPs that address the processing, analysis and reporting of safety information to ensure proactive surveillance of products.

8. Participates in health authority interactions (both written and verbal) and inspections regarding safety and risk management

9. Participates in due diligence to evaluate new potential in-licensing and out-licensing opportunities.

10.Provides supervision, leadership and professional development to members of the pharmacovigilance department.

1）根据欧美仿制药市场现状和发展趋势提出制药业务国际化发展战略；

2）根据欧美市场情况，评估公司可海外销售的产品或引进合作项目，负责项目评估立项、研发注册、生产、销售工作；

3）组织优化公司生产质量管理体系，达到国际标准；

4）根据国际注册要求，负责产品技术改进、质量提升、技术平台建设等；

5）通过行业会议报告等形式提升公司在国际仿制药领域的影响力，通过培训等方式提升团队能力。