1. Be fully responsible for the management of clinical research projects and the project schedule, budget, resources, risks, and quality control;
2. Responsible for promoting clinical research to ensure that all cross-departmental tasks are completed according to the research plan, and participating in the formulation of the clinical plan, plan revision, and other relevant documents;
3. Lead one or more clinical operation teams including clinical researchers and clinical research assistants to ensure timely and quality completion of work tasks, report research progress and problems, and provide solution plans; responsible for the development of clinical research and feasibility study of research centers and the decision on the selection of research centers;
4. Assist the clinical medicine team in reviewing clinical research data, including the writing of clinical research reports, publication of research data and internal, and external publicity of the company;
5. Develop clinical outsourcing business requirements and supplier selection according to the project.
1. At least a bachelor’s degree in life science (clinical medicine and pharmacy related major), with 2 years or more experience in clinical project management; Experience in pharmaceutical, biotechnology and CRO companies; international clinical research experience is preferred;
2. Familiar with ICH GCP, clinical trial design, and regulatory procedures;
3. Fluent in written and spoken English and Mandarin;
4. Strong interpersonal skills, ability to work independently and in a team, and the ability to lead a cross-department team in a fast-paced working environment
1. Support the management of clinical research of the company and the formulation of clinical trial development plans of the department;
2. Execute clinical trials in accordance with relevant laws and regulations to ensure the quality and schedule of clinical trials;
3. Responsible for developing or reviewing project management plans to ensure that clinical trials are conducted in accordance with cGCP, SOP, and other relevant clinical research guidelines and regulations;
4. Responsible for the progress management of each clinical study and timely solving problems in the process of clinical trials;
5. Responsible for maintaining good cooperation between internal and external partners of the company.
1. Major in medicine, clinical medicine, nursing and related fields, master degree is preferred;
2. Engaged in drug clinical research for more than 1 year, with project management skills and experience;
3. Fully grasp the clinical trial management standards and relevant laws and regulations of drug management;
4. Proficient in English
1. Responsible for communicating with commissioned research companies and following up the research progress, supervising the work of the research unit, and proposing technical requirements according to the real-time registration regulations;
2. Responsible for writing part of the application materials, reviewing the registration materials written by the commissioned research units, giving feedback, and supervising the modification;
3. Responsible for sorting and submitting registration materials and tracking the registration progress, giving timely feedback and coordinating to solve the problems of review and approval;
4. Organize communication with CDE as required, write communication materials and submit them to CDE;
5. Responsible for the international registration management of existing projects, understand and learn the international registration requirements, communicate with the registration agency, track and manage the registration affairs;
6. Timely follow up, familiarize with, and interpret laws and regulations related to CFDA and CDE drug research, collect the dynamic progress of industry regulations, and provide training and policy support for drug research team.
1. Familiar with the whole process of drug research and development and relevant laws and regulations of drug registration;
2. Excellent communication and coordination skills, meticulous and patient, and proactive and professional;
3. More than 3.5 years work experience in drug registration and declaration, good drug registration network resources; large pharmaceutical company registration management experience is preferred;
4. Good writing ability in Chinese and reading ability in English is preferred;
5. Those who had CTD data to report to ANDA or NDA and successfully obtained approval will be preferred.
1. In charge of pharmacokinetics research in and out of clinical precursors;
2. Responsible for validating biological sample analysis methodology and sample testing;
3. Other work arranged by leaders.
1. At least a bachelor’s degree in pharmaceutical analysis/pharmacokinetics/pharmacy, or other related field;
2. Have relevant experience in biological sample analysis and pharmacokinetic research, and understand or be familiar with the establishment and verification of preclinical pharmacokinetic research and biological sample analysis methods;
3. Experience in IND application research is preferred;
4. Responsible, hard-working, with good communication skills and teamwork spirit.
This position will assist Project Specialists in overseeing various pharmacological/toxicological tests and clinical trials. Assist the regulatory team in completing the local and international registration of innovative drugs. Evergreen Therapeutics, Inc. will provide systematic training and guidance to those who fill the position.
1. Dock with domestic and foreign preclinical and clinical trial bases
2. Supervise the implementation of various pharmacological/toxicological tests
3. Prepare documents under the guidance of experts
4. Participate in internal/external communication regarding the project
5. Coordinate the translation, compilation, and proofreading of documents under the guidance of native English experts
6. Study and participate in the electronic declaration of new drugs (eCTD)
1. At least a bachelor’s degree in medicine, pharmacy, biology, chemistry, or other related field
2. Proficient in English reading and writing; overseas study experience is preferred
3. Excellent communication and coordination skills
4. Excellent team spirit
5. Basic understanding of drug development and registration
6. Able to go to Nanjing to participate in the company's technical training for 3 months
7. Can participate in the company's business and technology travel in Europe and America in the next 1-2 years
This position is mainly to assist project experts to complete in vitro pharmacodynamics and pharmacokinetics related evaluation, study the mechanism of action of drugs, explore new therapeutic targets, and provide technical support for the company's innovative drug registration and patent application at home and abroad.
responsibility
1. Assist to complete the in vitro pharmacodynamics and pharmacokinetics evaluation of the compound
2. Responsible for the design and implementation of in vitro experiments, as well as the analysis and summary of experimental results
3. Responsible for the collection and analysis of relevant literature
4. Work closely with other departments within the company
5. Supervise the implementation of pharmacology/toxicology experiments in cooperation with the company
1. Bachelor degree or above in pharmacology, biochemistry, molecular biology, etc
2. Proficient in cell culture and molecular biology related experimental techniques
3. Familiar with routine in vitro compound pharmacodynamics and pharmacokinetic evaluation techniques
4. Good English literature retrieval, analysis and induction skills
5. Good team work spirit
