1. Responsible for the construction and optimization of animal disease model;
2. Be responsible for designing reasonable animal experiment scheme, scheme optimization and method development, selecting appropriate animal model, leading project team personnel to conduct pharmacodynamic research, controlling project progress and reporting regularly;
3. Be responsible for the screening of pharmacodynamic research institutions and project tracking management, give technical guidance, ensure the accuracy and integrity of research data, and regularly report the project progress;
4. Be responsible for writing the efficacy materials in the clinical application materials of new drugs;
5. Be responsible for the teaching and guidance of the personnel in the project team.
Job requirements:
1. Master degree or above in pharmacy, animal medicine, biology and basic medicine, more than three years of relevant experience, master is preferred;
2. Experience in drug (small molecule) efficacy and pharmacological research projects;
3. Be familiar with tumor models, and have the experience and ability to independently design relevant experiments, project operation management and result analysis;
4. Experience in drug ind (clinical access) application project is preferred.
Job responsibilities:
1. Responsible for the overall planning of clinical research, including the investigation of clinical trial progress and relevant information of similar varieties at home and abroad, clinical evaluation and feasibility analysis, and the formulation of clinical development strategy;
2. Be responsible for the formulation of the company's project clinical research scheme, communicate with clinical medical experts and review experts in the process of clinical scheme design and clinical research, and preside over internal scheme discussion, external scheme consultation meeting and project related professional meetings;
3. Be responsible for clinical academic support during the development of clinical trial projects, such as the writing, review and revision of CRF, informed consent, investigator manual, etc;
4. Write, review and revise clinical application materials such as clinical summary report and clinical research review;
5. Be responsible for the clinical program training of other members of the project team and medical academic support during the development of clinical trials, such as medical audit and medical quality assurance;
6. Set up a medical team, cooperate with the clinical operation team to ensure that the clinical trial is carried out as planned, and answer / communicate relevant questions / information in the clinical of the product;
7. Other related work arranged by the company.
Job requirements:
1. Medical doctor, more than 5 years of clinical research experience in pharmaceutical R & D enterprises or CRO, familiar with the field of metabolism is preferred;
2. Be familiar with ind, clinical phase I to III trials, and have strong clinical trial design and evaluation ability;
3. Have solid basic medical knowledge; Familiar with ICH-GCP requirements; Familiar with drug clinical development business process and regulatory requirements;
4. Good English reading ability and basic medical writing, fluent oral communication;
5. Have rich project management experience, good communication skills and cross departmental cooperation ability.
Job responsibilities:
1. Participate in the formulation of toxicological research plans at different stages of new drug development, effectively promote the project progress, and timely summarize and report the research progress;
2. Formulate toxicological experimental schemes, analyze and summarize experimental results, and solve scientific or technical problems in the process of experiments;
3. Manage the partners and cro, track the experimental progress, communicate with the research leader, coordinate the preparation of test articles, monitor the experimental site, and review the original experimental data and relevant toxicological reports;
4. Archive relevant data and write toxicological review according to the requirements of new drug registration regulations;
5. Track the research and development status and literature of drugs with the same target, and guide the development of target products;
6.Other work arranged according to project requirements.
Job requirements:
1. Master degree or above in Pharmacy (toxicology, pharmacology, pharmacokinetics, analysis, etc.), medicine or biology;
2. At least 3 years working experience in toxicology; Experience in GLP subject leader (SD) is preferred;
3. Independently complete the scheme design, experiment implementation, data analysis and summary of toxicology experiment;
4. GFamiliar with GLP and other toxicological regulations; Experience in writing chemical drug application or review data is preferred;
5. Excellent Chinese and English reading and writing skills and literature research ability.