Applied Pharmaceutical Science
Achievement Passion Sincere
1. Responsible for the whole process for clinical and non-clinical trials of innovative drug,including protocol development, clinical sites selection, study conduction and quality control etc;
2. Responsible for SOP development and effective implementation;
3. Responsible for communication with CRO, KOL, clinical experts, and other clinical research resources, assist in developing clinical development strategy and protocol to ensure clinical study conduct smoothly;
4. Responsible for clinical trials summarizing and reviewing, investigator meeting organization, regulatory communication meeting preparation, etc.; Responsible for issue management and problems resolving during clinical study conduction;
5. Responsible for building medical team, establish training system, optimize related process of clinical operation regularly;
6. Follow up the study completion of each stage, tracking the study status, identify and resolve issues timely, ensure study conducted in high quality and study timeline is meet;
7. Provide medical science support for new product registration and clinical trials conduction.
1. Master degree and above of medicine, pharmacy, biology and other related majors;
2. Familiar with the requirements of ICH-GCP, GCP and related registration regulations. Demonstrated good leadership, decision-making ability, good management and communication skills. Familiar with the drug development process, regulatory requirement of China, Europe and the United States, experience of drug registration in multiple countries is preferred. Working experience in the international pharmaceutical company or CRO is preferred;
3. More than 8 years working experience of clinical development, more than 5 years working experience of team management. Experience of IND submission and approval of one innovative drug or imported new drugs at least;
4. With the good capability of execution, learning, planning, analysis, negotiation, organization and coordination, resource integration.
1. According to the overall plan of the company, make annual business work plan including cooperation resources development, strategies and plans of license-in new projects, seeking and license-in products, and feasibility analysis;
2. Seeking potential business development and cooperation opportunities, conducted market analysis and screening, organized internal project application, and compose business negotiation proposals;
3. Responsible for communicating and negotiating with target customers, promote cooperation and contract signing by dealing with obstacles in the process, and ensuring timely progress and completion of the project;
4. Responsible for business negotiation and telephone conference with potential customers all over the world, make efficient communication of product development plan and product registration issues;
5. Responsible for following up the continuous promotion of cooperation projects, coordinating and solving problems during the progress.
1. Bachelor degree or above, major in business, marketing, biochemistry, pharmacy or clinical medical;
2. More than 10 years of business development experience in medical industry, more than 5 years of management experience in the same position, have a deep understanding of the work content in this field;
3. Excellent public speaking skills, communication and coordination skills, organization and planning skills, and strong crisis management skills;
4. Strong logical thinking and analytical judgment ability, sharp market insight and strong sense of risk control;
5. Familiar with innovative API and drug manufacture, registration and related regulations;
6. In-depth understanding of biopharmaceutical industry, business development background in biopharmaceutical industry is preferred;
7. Use English as working language.
1.Responsible for the whole process management of pharmaceutical research and development, such as the molecular design and chemical synthesis, the control of quality and progress, patent discovery and the solution of key problems;
2. Keeping sensitivity to the new platforms and technologies of worldwide about new drug discovery, mastering industry news timely, improving research and development strength and efficiency in the whole team, and providing professional support for project selection, approval and cooperation;
3. Searchcollect and sort the literature about the new target within MedChem-Department independently;
4. Design synthetic route and solve chemical synthesis problems independently;
5. Act as a new drug discoverer including designing the active compound and investigating the SAR; Submitting stage achievement report and the work plan next stage on time;
6. Responsible for patent writing, review and follow up for innovation molecule, and ensure effective protection of intellectual property;
7. Responsible for the related management of the MedChem-Department, including subordinates assessment, the SOP, staff training and team construction, etc.
1. Master degree or above in Organic Chemistry, Medicinal Chemistry or relevant chemical science field; At least 5 years of new drug discovery experience and team management experience; PhD degree preferred;
2. Strong chemical knowledge and highly skilled synthetic chemist with the ability of design and conduction of organic experiment, operation of all kinds of instruments and apparatus in organic chemistry lab; able to solve chemical synthesis problems independently;
3. Master basic skills of organic chemistry, understand computer aided drug design（CADD）, willing to learn knowledge in Medicinal Chemistry and new drug research and development;
4. Strong sense of responsibility, devotion, innovation and team work. Good organization, coordination and team management skills.
1. Responsible for the quality research of new drug R & D projects, and formulate the quality research work plan;
2. Lead team member to complete the assigned R & D tasks, give guidance to the technical problems in the R & D process, and organize the drafting and review of technical data on quality research;
3. Responsible for the daily management of the lab, Design and implement theresources and personnelaccording to project need;
4. Familiar with FDA, ICH, NMPA and CDE regulations and requirements, andprovide analytical method trouble shooting support when required;
5. Responsible for reviewing and analyzing inspection data, original records of various experiments and application materials of quality research to ensure that the research is true, scientific, compliant and traceable;
6. Support the daily research work of chemistry , pharmacology department and quality research related to outsourced research;
7. Support daily lab management responsibilities including but not limited to training, team building and performance evaluation, etc.
1. At least master or above degree inchemistry, pharmaceutical analysis , applied chemistry or other equivalent scientific discipline, minimum of 5 years working experience in new drug quality research and application, minimum of 3 years working experience of drug analysis project management;
2. Carry out new drug quality research and stability research, and be competent to write CTD data of new drug application. Experience in Sino US double reporting (IND and NDA) is preferred;
3. Establish quality research and stability test protocol and report, write and review the related investigation and application report;
4. Familiar with drug R & D process and related project management knowledge;
5. Have the ability to analyze and solve problems, with strong communication, leadership and management skills, excellent professionalism and teamwork spirit.
1. Responsible for technology platform establishment, new technology development and platform capacity construction according to the annual plan of in vitro pharmacological platform construction;
2. Responsible for guiding platform members to implement project plans according to in vitro pharmacology platform project plans. Such as: in vitro enzyme screening platform, related enzyme expression and purification platform, stable transformation engineering cell line platform, cell efficacy screening platform, mechanism research platform and other evaluation work; Be able to find project problems and propose reasonable solutions.
3. Guide the person in charge of in vitro pharmacology platform to manage and maintain the R&D platform. Participate in the review of external R&D platform plans and reports; Participate in process follow-up, risk control and result evaluation;
4. Guide the person in charge of the in vitro pharmacology platform to conduct the in-platform management. Such as: compliance management, IP protection, SOP compilation and upgrade, laboratory supplies management, laboratory and equipment daily maintenance, new equipment introduction, etc.
1. PhD or Master degree in pharmacology, cell and molecular biology or related disciplines;
2. At least 3 years of pharmacological work experience in new drug development; Experience in pharmaceutical company or related CRO company is preferred;
3. Familiar with enzymological protein expression, purification and screening, establishment of genetically engineered cell lines and drug molecular mechanism research, etc.
4. Solid and comprehensive theoretical knowledge, able to deal with complex experimental problems of cell and molecular biology;
5. Strong sense of responsibility, execution and professional ethics, with strong sense of standardized management;
6. Passionate about R&D and technical work, willing to share and communicate, able to actively promote and communicate with members of the platform group, with certain organizing and reporting abilities.