【Pharmaceutical Preparation Director】
- Responsible for R&D talent development and skill training in the Formulation Department to build a competitive R&D team;
- Responsible for formulating and reviewing project plans and programs, conducting project management, and leading the FormulationDepartment to complete project R&D in accordance with the QbD concept and ICH related requirements;
- Leading the Formulation Department to carry out pharmaceutical preparation screening, process research and optimization, to achieve the conversion from pilot scale to batch scale production, and complete clinical trials;
- Responsible for Optimization of the formulation development process and effective implementation to ensure that the R&D project is completed on schedule;
- Responsible for preparing and reviewing the application materials in accordance with CTD requirements to ensure the authenticity and integrity of the R&D project.
- Master degree or above with major inpharmaceutical science or related. Over 10 years of working experience. More than 5 years of management experience on equivalent positions, Qualification requirements could be adjusted for outstanding candidate;
- Can carry out research on formulation prescription process according to QbD concept, familiar with risk analysis and control, process amplification, change control, technology transfer, verification and other requirements;
- Rich experience in oral preparations and other preparations;
- Familiar with the registration regulations of pharmaceuticals (domestic or foreign) and related technical guidelines, familiar with preparing and polishing of CTD format filing materials;
- Rich theoretical and practical work experience, can independently undertake the formulation work in innovative drug R&D, and solve technology problems related to the formulation prescription process and the pilot production that occur in R&D;
- Proficient in English, strong sense of responsibility, good communication and coordination skills and teamwork spirit;
- Familiar with the innovative drug R&D process and milestones, experienced in innovative drug application process.
【Clinical Trials Registry Director】
- Responsible for the application of the Clinical Trials Registry for all new drug projects of the Company; annual and quarterly targets setting; supervising the implementation and effective completion of the plan; leadingthe organization of the registration and filing leadership team; leading and directingcross-functions coordination to achievethe registration milestones;
- Follow up with changes in the drug registration policy, maintain good relations with competent authorities, establish resource pool and connections with relevant drug registration regulators and experts;
- Responsible for coordinating with CFDA experts and pharmacy experts to solve problems related to regulations and registration in the process of drug R&D and registration; assisting in handling matters related to national, provincial and municipal regulators and other superior authorities on drug regulation, quality supervision, drug testing and inspection;
- Keep following the latest developments in product R&D technology and registration laws and regulations;
- Responsible for the communications, information support and training of registration policies and regulations within the Company.
- Master degree or above with major in clinical medicine, pharmacy, etc.;
- More than 8 years of clinical and registered work experience, at least 5 years of registration management experience, and has successfully submitted drug registration;
- Familiar with the entire workflow of the Clinical Trials Registry;
- Strong capability in planning and implementation, hard-working, self-disciplined, organized, and good communication and coordination skills.
【Clinical Project Manager】
- Responsible for managing new clinical projects launched by the Company, formulating clinical trial plans, assisting in the design of clinical trial protocols and related documents, preparing summary reports, etc.;
- Ensure that the clinical research process is carried out in accordance with the GCP and the research protocol;
- Identify and deal with various problems and risks that occur during the test;
- Responsible for contact and communication with researchers, CROs, etc.;
- Responsible for the management and test review of clinical research projects to ensure the quality and progress of the research project;
- Responsible for training program to clinical trial inspectors from time to time;
- Other work assigned by the leadership.
- Bachelor degree or above, major in medicine or related subjects;
- experience in clinical trial management, hospital working, CRA, and project management is preferred;
- Being healthy and able to adapt to business trips;
- Strong teamwork and hard-working spirit;
- Excellent communication and self-learning skills;
- Capable of English reading, writing and translating;
- Familiar with CFDA policies, laws and regulations, as well as GCP specifications. GCP certificate is preferred.
- Fully responsible for the statistical work of the Company’s clinical trial projects;
- Responsible for the test design, complete the calculation of sample size and statistical test efficiency;
- Prepare statistical analysis plan, including analysis form design for each study;
- Responsible for data management and related work;
- Responsible for randomization and blinding/masking;
- Responsible for CRF design, collaborate with database administrator to build database;
- Identify key variables in the database;
- Write SAS programs to generate tables, lists, charts, and statistical analysis results;
- Participate in blind reviews and work with data administrators to prepare blind review reports;
- Prepare a statistical analysis report;
- Provide guidance and training for clinical research staff;
- Provide statistical consultation and guidance to other teams.
- Master degree or above in medical statistics, health statistics, biostatistics, etc. More than 3 years of experience in statistical analysis of drugs, CRO work experience is preferred;
- Deep basic theoretical knowledge and rich practical experience in application;
- Familiar with the requirements for clinical pharmaceutical studies, but not limited to the requirements of GCP and IGH GCP;
- Familiar with various experimental design methods, proficient in clinical trial I-IV design and related workflow;
- Good data analysis skills, skilled use of SPSS or SAS statistical software;
- Familiar with CDISC data standards;
- Deep understanding of the data of clinical trials, good at communicate with data management personnel, and high work efficiency;
- Capable of communication and negotiation with external statistical experts;
- Pay attention to and fulfill the commitments in terms of service quality，satisfy the biostatistics analysis milestones;
- Strong organizational coordination and management communication skills, positive and optimistic work attitude, affinity and teamwork spirit.
【Data Management Manager】
- Complete the design/building/verification/testing of EDC within the specified time according to the clinical research protocol;
- Provide EDC training to the Company’s in-house project staff (such as CRA, CRC, PM, etc.) after the project EDC goes online;
- Participate in project meetings, track project progress, and ensure that all data management tasks milestones are satisfied with high quality;
- Develop a data management plan for the clinical research project and submit data management report as planned;
- Check the data according to the data management plan, complete the data verification report, and question the suspicious data;
- Establish medical terminology glossary for the project and independently code the clinical medical terminology;
- Complete independently the drug code (ACT code) and SAE consistency check.
- Prepare the information needed for the blind review meeting and participate in the blind review of the database;
- Provide training and guidance to unexperienced employees;
- Archiving of databases and related management files;
- As the case may be, work as the author or reviewer of the data management related SOP, and strictly enforce the requirements of the departmental SOP to ensure the quality of everyitem in the data management;
- Manage vendors of data management system to ensure that the services and standards provided by the suppliers meet the scope of work;
- Conduct data management work in accordance with relevant regulatory requirements.
- Bachelor degree or above in medicine, pharmacy, epidemiology, biology or computer related disciplines, and 4 years of data management experience, DM project management experience; or master degree in medical, pharmacy, epidemiology, biology, and computer or equivalent education background, 3 years of data management experience, DM project management experience;
- Experience in CRF database building and listing, strong EDC theoretical knowledge, and more than 1 year of experience in EDC;
- Familiar with the relevant regulations of clinical trial data management;
- Strong communication and coordination skills to ensure timeliness, accuracy, integrity and validity of clinical research data;
- Good planning, organization and problem-solving skills;
- Computer skills, proficiency in Microsoft Word, Excel and PowerPoint;
- Ability to manage multiple tasks and projects simultaneously and effectively.
- Working and thinking independently. Capable of process improvement if appropriate.
【Quality Control Manager】
- Responsible for the optimization and improvement of the Company’s clinical operation quality system in accordance with relevant regulations, and overall management of quality control system operation;
- Support the QA ofclinical project in pipeline;
- Routine internal and external quality auditing;
- Responsible for the QC of suppliers’ services.
- Bachelor degree or above in medicine related major;
- More than 3 years working experience in quality control positions;
- Familiar with QC related regulations and procedures;
- Proactive and good at communication.
【PHD in Pharmaceutical Chemistry】
- Assist the superiors in the investigation and initiation of innovative drug projects, and conduct literature research to explore lead compounds for drug discovery;
- Compound design according to SAR, complete design and evaluate the synthesis route of the compound, and provide guidance to the synthesis of the compound;
- Optimize the reaction conditions and submit a synthetic route suitable for scale-up production;
- Sort out and archive product development technical information and data in a timely manner, complete the preparation, filing and archiving of raw material synthesis filing documents, establish a clear and complete experimental records, and manageR&D reports;
- Responsible for providing professional pharmacochemical evaluation opinions for project introduction or project evaluation;
- Other related work in medicinal chemistry R&D.
- Doctor degree in organic chemistry and medicinal chemistry;
- Familiar with drug development process, participate in or lead the study of compound structure-activity relationship and new compound design and synthesis;
- It is preferred to have the ability to use professional medicine design software, such as Schrodinger, Discovery Studio or Sybyl;
- Experience of team management and leading new drug R&D projects;
- Strong capability of organization, coordination, problem analysis and solving;
- Fluent English reading and writing, English listening and speaking ability is preferred;
- Strong professionalism, responsibility and good teamwork spirit.
【Organic Synthesis Doctor】
- Proficient in the chemical reactions of project experiments, and perform the synthetic reaction with certain difficulty with the assistance of relevant personnel;
- Master product separation and purification technology, map analysis, and structure identification (NMR, HPLC, MS);
- Perform multi-step synthesis according to the experimental steps and solve the simple problems that appear in the experiment;
- Write and keep the experimental record clearly and completely.
- Doctor degree in organic chemistry, applied chemistry, medicinal chemistry and related majors;
- Familiar with various organic synthesis operations, the spectrum analysis and separation and purification technology;
- Solid professional knowledge, strong ability of learning and hands-on skills, capable of problem analysis and solving;
- Dedicated and committed to the synthesis work, with good sense of responsibility, teamwork and innovative spirit.
- Responsible for the research on clinical medicine projectsand preparation of clinical trial planning;
- Responsible for clinical academic support during the development of clinical trial projects, such as research medical records, CRF, informed consent, patient diary cards, writing, reviewing and revision of the researcher’s manual;
- Responsible for writing, reviewing and revising the clinical part of the filing documents, including clinical summary report, clinical research review etc.;
- According to the needs of the Clinical Project, communicate with clinical medical experts and review experts on clinical program design;
- Participate in clinical program discussions, summary meetings, and provide relevant academic support;
- Provide academic support for the Company’s new drug registration and new drug clinical trials;
- Responsible for the interpretation of clinical effectiveness and safety;
- Develop and implement clinical development strategies for new drugs;
- Responsible for collecting, sorting and reporting the safety information of the Company’s products;
- Assess adverse events and their effects in clinical studies;
- Provide academic support on medical literature and information;
- Provide relevant training for internal and external personnel;
- Participate in academic events and maintain good relationships with experts in the field of oncology.
- Doctor degree in clinical medicine, experience in medical manager of pharmaceutical company is preferred;
- Strong medical editing skills, proficient in medical literature retrieval and reading and various computer office software;
- Positive and serious working attitude; optimistic, affinitive and teamwork spirit; strong resistance to stress;
- Familiar with the characteristics of the Company’s products and clinical research carried out in different disease areas;
- Good communication with clinical trial center experts and CFDA.