1. Participate in the work related to IIT and IND of the company, including the writing and review of phase I-III clinical research scheme, clinical research summary report, investigator's manual, instructions, etc., and issue clinical strategies and schemes based on preclinical data;
2. Participate in the decision-making of major medical technical plans related to new drug R &D, the formulation of medical plans, the leadership and review of the preparation of summary reports and project application materials;
3. Participate in preclinical pharmacology and toxicology research, cooperate with leaders to conduct high-level academic exchanges with academic authorities and experts in relevant fields, understand the clinical demand for the R & D products, and cooperate with the R & D department to formulate the clinical strategy and clinical scheme design for new drug R &D;
4. Carry out continuous clinical research medicine related training and project management for relevant personnel participating in clinical trials, and control the overall progress and quality of the company's clinical research projects;
5. Be responsible for medical supervision and quality control of clinical data during clinical trials;
6. Work closely with internal teams and external partners and focus on the implementation of clinical research plans; Review, analyze and summarize clinical trial data, and provide opinions / suggestions on safety, effectiveness and exploratory endpoint decisions;
7. Communicate and interact with different drug regulatory review institutions, discuss the clinical trial design scheme, and carry out corresponding work within the company to effectively promote the clinical trials of projects / products;
8. Participate in the management and quality control of CRO and other suppliers;
9. Complete other related work.
1. Clinical medicine, drug registration and management, pharmacy (pharmaceutical preparation, drug analysis, Pharmaceutical English, virology and other majors are preferred) or other medical (Pharmacology, toxicology or clinical) and other related majors, master's degree or above;
2.3-5 years of clinical trial project implementation and management experience, with gene therapy ind experience or Sino American double reporting experience is preferred;
3. Having international multi center clinical development experience is preferred;
4. Be familiar with the laws, regulations, design, process and management related to clinical trials at home and abroad;
5. Have successful application experience in innovative drug ind and NDA projects;
6. Good English listening, speaking, reading and writing skills;
7. Strong sense of responsibility; Good expression and communication skills; Good flexibility and teamwork.
If you are interested in joining us, please send your full resume and application to email@example.com or submit it via the contact form.
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