Responsibilities

1. Participate in the development of clinical strategies and plans for new drugs and be responsible for the medical evaluation of clinical protocols, including clinical feasibility and potential risk analysis; support clinical study design, including the selection of therapeutic areas, target populations, treatment regimens, and control groups.

2. Interact with investigators and regulatory authorities during the clinical application phase of new drugs to discuss clinical development plans.

3. Responsible for the development of clinical trial materials (investigator manual, trial protocol, informed consent form, case report form, subject diary, etc.).

4. Interact with investigators during the clinical operations phase to provide information on investigational drugs and ongoing assessment of medical effectiveness and safety.

5. Provide medical support during the clinical operations phase, including review of protocol violations and operational consistency to ensure medical compliance with the protocol, responsible for review and interpretation of clinical data, and communicate with the study site and related parties regarding relevant medical issues in the EDC system to resolve queries.

6. Conduct medical assessments of individual subjects, including inclusion/exclusion criteria, adverse events/serious adverse events, medical history, concomitant medications, laboratory tests, etc., and provide summaries of necessary information to provide a basis for decision making by the project team and investigators.

7. Be responsible for relevance determination of adverse events, provide clarification or confirmation to investigators on relevant issues, and be responsible for relevance assessment.

8. File and update safety reports (DSUR) during R&D.

9. Be responsible for researching and summarizing the clinical data of similar varieties at home and abroad.

Requirements

1. Doctor Degree in clinical medicine, internal medicine, general medicine, oncology, etc., with relaxed conditions for those with excellent ability.

2. At least 3 years of experience as a clinician, preferably as a medical director in a pharmaceutical company.

3. Good English application skills.

Responsibilities

1. Responsible for the planning of R&D projects and coordinating the progress of collaborative projects.

2. Design and evaluate synthetic process routes for API or intermediate compounds, write or review synthetic technical proposals, and guide technical staff to complete route opening and process optimization.

3. Lead the research team to design and synthesize the precursors and implement structure optimization.

4. Responsible for team building of the department, solving technical problems encountered in the experimental process, responsible for arranging the work schedule; reporting the work progress of the department on a regular basis.

5. Responsible for the training of new employees and the safety management of the laboratory.

6. Complete other work assigned by the direct supervisor.

Requirements

1. Master degree or above in organic chemistry, medicinal chemistry or other related fields.

2. More than 10 years of relevant new drug development experience.

3. Rich experience in new drug development, familiar with the complete innovative drug development process and key nodes, and understanding of domestic and international innovative drug development dynamics.

4. Good writing and oral communication skills in English and Chinese.

5. Clear logical thinking, excellent scheduling and execution skills.

6. Integrity, honesty, excellent work ethics, professionalism and teamwork.

Responsibilities

1. Responsible for the supervision of clinical trials, ensuring that all trials are conducted in strict accordance with clinical trial protocols, standard operating procedures/internal operating procedures and relevant national industry regulations.

2. Assist the project manager in the management of the contract research organization, provide overall quality control and management of the research projects under his/her responsibility, complete the full start-up, execution and center closure related work of the clinical trials in China on time, and communicate and coordinate with other project-related department personnel in a timely and efficient manner.

3. Contribute to the implementation of patient recruitment strategies and contingency plans in collaboration with other functional departments and vendors.

4. Responsible for timely communication with supervisors in the selection of trial centers, investigators and development of trial budgets.

5. Responsible for assisting in the completion of relevant reports and trial records to ensure the accuracy, validity and completeness of data collected at the trial site; ensure that all adverse events (AEs) / serious adverse events (SAEs) / product quality complaints are reported and appropriately documented within the required reporting timelines. For AEs/SAEs, ensure that they are consistent with all data collected and the information in the source documentation.

6. Responsible for feedback of questions from the monitoring process and ensuring that data entry and query answers are completed by the investigator within the expected timeframe.

7. Work closely with the contract research organization to ensure that quality issues identified during routine surveillance visits, QA audit visits and other types of visits are resolved and that relevant corrective and preventive actions (CAPA) are completed.

8. Responsible for project related documents, material and drug deployment, and timely communication with project managers regarding safety, material, time points and financial budgets.

9. Act as the external representative of the company and client to deliver important company and client information to investigators in a timely manner, cultivate and maintain good relationships with investigators; be good at coordinating relationships and conflicts between projects.

10. Check the integrity of research documents and ensure that document retention requirements are met, including keeping them in a secure location at all times; review and sign routine visit reports and other TMF documents for all responsible projects.

11. Perform other duties as assigned by the direct supervisor.

Requirements

1. Bachelor  degree or above in clinical medicine, pharmacy related majors.

2. 1-3 years of clinical monitoring experience, familiar with the workflow of I and II clinical trials.

3. Understanding of the documentation requirements in clinical trials, i.e. traceability, informed consent, case report form (CRF), etc., knowledge of clinical research quality management standard GCP, and understanding of the latest regulations and requirements of the industry.

4. The ability to identify various problems in the process of drug clinical trials, rigorous and standardized drug clinical trial supervision and promotion.

5. Excellent communication and coordination skills, better communication with investigators, contract research organizations, laboratories, suppliers.

6. Work meticulously, have patience, can carefully review relevant information, and have certain writing skills.