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. A master's or doctoral degree in pharmacology or related pharmacy, and has 3 years experience in pharmaceutical companies.
2. Experience in drug development, pharmacokinetics, and communication with regulatory agencies.
2, familiar with the relevant requirements of drug administration on drug metabolism, pharmacokinetics, efficacy and clinical trial design.
4, can balance and clear work priorities，on the basis of ensuring the quality of work
5, take the initiative, have good verbal, written communication and presentation skills.
6. Have the ability to work in cross-functional teams.
7, 10% of the time each year will travel internationally/domestically.