Director, Clinical Development
1. Lead the clinical research team to formulate and implement the responsible product clinical development
plan. Ensure that the clinical development plan is in line with the clinical development strategy and
operation, and work with the clinical research team to provide estimates of the budget and resources
required for the implementation of the clinical research plan.
2. Be responsible for or assist in the preparation and revision of clinical research project registration application
and clinical research related documents, including but not limited to clinical research protocol, investigator
manual (IB), informed consent form (ICF), CRF, research summary report (CSR), etc;
3. In the process of clinical trial, be responsible for medical supervision and review of medical data, be
responsible for the training of clinical research scheme for researchers and project managers (supervisors), and
answer questions about clinical research scheme;
4. Keep track of the latest progress and trends in the treatment field, collect and analyze industry and medical
information, and ensure professional and accurate evaluation of indications, medical practices, treatment
guidelines and published literature related to the company's research drugs.
5. Be responsible for leading relevant clinical teams to formulate other clinical science related strategies or
plans, such as data analysis, interpretation, management of KOL and external clinical expert consultants in
relevant treatment fields, data / article publication, etc;
6. Other tasks assigned by the superior.
1. Identify with corporate culture, have ambition and sense of responsibility, work steadily and efficiently, and have a good sense of cooperation;
2. Master degree or above (Bachelor degree requires clinical medicine as major); At least 2 years working
experience as a clinician is preferred;
3. More than 5 years working experience in related treatment field or clinical research in pharmaceutical
enterprises or large CRO companies, such as clinical research, physician, medical manager, clinical project
manager, etc. working experience in medical science related to new drug clinical research in related treatment
field is preferred;
4. Have an in-depth understanding of the knowledge and progress in relevant treatment fields,
be familiar with clinical experts in relevant treatment fields, and have a good
understanding of phase I-III new drug development.
5. As a team leader, have good organization, communication, coordination, problem solving and leadership
skills, be creative and team spirit, and be able to work under pressure;
6. Be familiar with the whole process of clinical research and understand the management norms of clinical
trials,
7. Have good professional, official document writing and oral expression skills; Strong overall thinking, analysis,
judgment, decision-making and problem-solving skills;
8. Skillfully use office software and be familiar with using the network to find professional and technical data;