1. Responsible for establishing and maintaining clinical research quality assurance system and training system, establishing clinical trial operation SOP, and regularly reviewing and improving / updating.
2. To ensure the quality of clinical trials, the operations and management of clinical trial projects and externally commissioned projects within the clinical group shall be regularly audited.
3. Assist the Clinical Affairs Director to formulate the annual quality training plan of the clinical department and the training plan for new employees.
4. Responsible for the due diligence and evaluation of the company's externally entrusted unit qualifications and SOP system.
5. Instruct the auditor to formulate the project audit plan, implementation plan and improvement measures.
6. Provide GCP, SOP and other training for clinical team members; conduct irregular training for clinical team members according to the problems found in the audit.
7. Responsible for the training, management and evaluation of the inspection team.
8. Responsible for the confidentiality of the research and development projects, technologies and data of the department.
1. Bachelor Degree or above, major in medicine, pharmacy and other related medical specialties recruited by the state;
2. At least 5 years of working experience in new drug clinical trial research or 5 years of clinical auditing experience in a large, comprehensive pharmaceutical company;
3. Those with clinical work experience or CRO company experience are preferred, and those with oncology projects are preferred.
4. Familiar with the corresponding domestic drug research and development, clinical research guidelines, regulations and policies;
5. Familiar with laws and regulations and the current status of clinical research and development at home and abroad, proficient in the entire process of clinical trials; rich in industry resources;
6. Proficiency in Chinese and English literature search, reading literature, writing and communication;
7. Modesty, studious, honest and reliable, with good communication and coordination, judgment and decision-making ability, team management and executive management capabilities.
1. Participate in drug R & D project establishment and budget preparation;
2. Responsible for external analysis and audit work;
3. Responsible for the overall quality research work of the project, and formulate the overall quality research plan according to the R & D progress requirements;
4. Responsible for the review of quality research technical schemes and reports, promote analytical experiment plans, and overcome analytical difficulties;
5. Responsible for the whole life cycle management of quality standards, including standard development, transfer, confirmation, verification and change;
6. Assist the director to carry out quality analysis laboratory construction and daily management;
7. Assist the director to carry out the daily management and performance assessment of the quality analysts, and be responsible for technical guidance and training;
8. Responsible for the establishment and maintenance of a standardized R & D analysis platform to ensure data integrity and scientific quality research;
9. Responsible for establishing and perfecting the management system and operation rules of R & D analysis, and drawing up the technical template for quality research.
1. Master Degree, major in analytical chemistry, pharmaceutical analysis or pharmacy;
2. More than 6 years of R & D analysis work experience, and those with large domestic R & D companies are preferred;
3. With more than 3 years of team management experience and good communication and coordination skills;
4. At least independently chaired more than 5 drug quality research work and at least 2 projects have been approved for production;
5. Familiar with the operation of conventional analytical instruments or testing equipment, such as HPLC, GC, dissolution apparatus, etc .;
6. Proficient in chromatographic separation principles, with solid professional knowledge in medicinal chemistry, analytical chemistry, etc .;
7. Familiar with the development and verification process of various analysis methods, and can independently conduct impurity spectrum research;
8. Familiar with the technical requirements for analysis in the application materials, have strong writing skills and language expression ability, and can independently write technical plans and reports;
9. Familiar with CFDA, FDA, ICH, WHO related quality research regulations, technical guidelines, and pharmacopoeia, able to write Chinese Pharmacopoeia format quality standards;
10. Familiar with enterprise GMP and cGMP management standards, able to analyze deviations and change management according to local conditions, establish quality control laboratories and standardized operation procedures;
11. Strong literature retrieval ability and a certain level of English, can independently retrieve foreign materials;
12. Have a strong active learning ability, be proactive, and be able to adapt to the high-intensity work rhythm and atmosphere.
1. According to the company's overall R & D requirements, research and grasp the development direction of the domestic and foreign pharmaceutical industry technology, and assist the CEO to establish the company's overall strategy and direction for discovering and developing innovative pharmaceutical products;
2. Fully responsible for the company's entrusted research and independent research and development of innovative drug product technology. Lead the team to carry out innovative research and development as well as topics ranging from drug target selection, lead identification and optimization of compounds, to determine candidate compounds in vitro in vivo clinical before evaluation of the entire drug development process;
3. Provide the project research direction and research ideas for the company's innovative drug development and screening work. Organize project technical demonstration and project review, make the innovative drug project's research direction meet the real clinical needs, and reduce project development risk;
4. Lead the team to carry out efficient R & D, systematically solve the key technical problems and difficulties encountered during the implementation of the R & D project, and propose clear solutions to the timely prediction and avoidance of R & D risks, promote and ensure that the project progresses according to the plan, and enhance the project Quality and technical implementation capabilities;
5. Track and master the international frontier progress of innovative drug research, collect relevant project information, and make reasonable suggestions for the company's innovative drug research and development direction;
6. Participate in the design and construction of the company's R & D center, establish and lead a first-class R & D team;
7. Undertake scientific and technological project topics at all levels, guide the completion of the selection of scientific and technological projects, project declaration, budget formulation, project implementation, acceptance summary, etc .;
8. Organize extensive international and domestic cooperation, introduce new drug projects or export new drug projects, and maintain good communication with domestic and foreign drug monitoring systems, clinical research bases, outsourcing service companies and other institutions.
1. PhD or above, overseas study abroad is preferred. Pharmacy, pharmacology, organic chemistry and other related majors;
2. With more than 10 years of experiences in the diagnosis and treatment of liver diseases, respiratory diseases and other diseases, and new drug research and development, he has been engaged in the research of innovative drugs in multinational pharmaceutical companies or well-known overseas universities and research institutions; he has participated in the project of innovative new drugs Approved listing experience;
3. Familiar with the innovative drug development model, process, technical requirements and related registration regulations;
4. Have professional opinions on disease pathogenesis, diagnosis and treatment status, advantages and disadvantages of different treatment drugs and unmet clinical needs;
5. Master the latest developments in biopharmaceutical research at home and abroad, and have the insight to grasp the development trend of the industry and the ability to select development projects in a forward-looking manner;
6. With professional pursuit and career ideals, a high degree of work enthusiasm and good professional qualities and business confidentiality awareness, strong innovation and development capabilities, and the courage to take responsibility and pressure.