Responsibilities:

1. Construct the non-clinical pharmacology and toxicology research and development platform, including disease models, pharmacological mechanisms, PK/PD, etc.

2. Take on and guide the evaluation and research of pharmacological and toxicological for candidate and pipeline projects.

3. Write and review the registration application materials for related research and development projects.

4. Organize relevant pharmacological research work on the expansion of new indications of drugs.

5. Participate in the research and establishment of new projects and provide professional advice in the fields of drug efficacy, pharmacokinetics and toxicology.

Qualifications:

1. Ph.D. in Biomedicine, Medicine, 5+ years relevant experience, experience in tumor, immune and nervous system drug development is preferred.

2. 2+ years of management experience in biotechnology/pharmaceutical companies.

3. Good reading and writing skills both in Chinese and English.

Good at thinking, strong responsible, good coordination skills and good communication skills.

Responsibilities:

1. Design and formulate the clinical study protocols and related documents of new drug projects to promote the smooth progress of drug clinical research. Through internal discussions and communication with external medical experts and review experts, determine clinical strategies, write clinical plans and related materials.

2. Assist in the data management of clinical projects and the review of statistical analysis reports and summary reports, as well as related work on drug safety alert systems and medical monitoring.

3. Write clinical study protocols, investigator’s brochures, clinical study reports and other clinically relevant documents (including but not limited to meeting abstracts, posters and manuscripts, etc.)

4. Participate in the planning, initiation, implementation and management of clinical trials, assist in the review of clinical CRO documents, and assist in the analysis of clinical data.

5. Cooperate with the research team to ensure the correctness of data in clinical related documents and ensure that medical writing complies with ICH and related regulations.

6. Write and revise the clinical study related documents such as clinical protocol, informed consent, investigator manual and clinical summary report, and assist in the application of IND and NDA.

7. Retrieve, organize and analyze the medical information of similar drugs at home and abroad.

8. Participate in the establishment of the company's new drug research and development project, and provide project approval support from a medical perspective.

9. Participate in the investigation and survey of the indications, competitive environment and variety differentiation of the company's clinical drugs under research, and formulate corresponding clinical strategies.

Qualifications:

1. M.Sc. or Ph.D. in Clinical medicine, Biomedicine or other related majors.

2. 3+ years of clinical research work experience, experience in tumor, immune and nervous system drug development is preferred.

3. Familiar with the whole process of clinical research and regulations of clinical trial management regulations.

4. Excellent written and verbal communication skills.

5. Good reading and writing skills in Chinese and English.

Good at thinking, strong responsible, good coordination skills and good communication skills.