Primary Responsibilities:
1. Responsible for overall clinical research activities for multiple pre- and post-approval studies, evidence generation and dissemination efforts, and budget oversight.
2. Support the design of appropriate clinical trials to meet the clients’ needs
3. Responsible for delivery of assigned clinical programs, through effective partnership with the clinical partners, to enable optimized engagement leadi to delivery of clinical project commitments (delivery on time, within budget and in compliance with regulations and SOPs).
4. Support clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations.
5. Lead a team of clinical research professionals to develop and deliver appropriate advice and medical support with all relevant clinical partners and cross-functional partners (e.g. Regulatory Affairs, Clinical Operation, Project Management, Data Management Business Development, etc), ensuring cross- functional alignment.
6. Lead a team of clinical research professionals to develop product clinical development strategy and executive plan.
7. Lead a team of clinical research professionals to interface and collaborate with key opinion leaders, investigators, IRB’s/EC’s, Regulatory Agencies.
8. Lead a team of clinical research professionals to ensure appropriate interpretation and dissemination of all evidence generated, including CSRs, Protocols, Synopsis abstracts, pre-IND/IND briefing documents, IB, Clinical Overview, etc.
9. Lead a team of clinical research professionals to development medical
monitor plan and function as a medical monitor in case of need, to ensure the quality and safety of the project, including but not limited to the medical query management, monitoring of SAE and protocol deviation, eCRF design eview, medical coding review, etc.
10. Develop an efficient team in line with company’s values and establish effective working environment.
11. Follow SOP, GCP and other requirements to ensure the correct implementation of clinical trials, and provide training and guidance to team members.
12. Strengthen the management of medical affairs department in assigned clinical trial projects, formulate policies for planning, implementation, tracking and communication, and ensure the completion of the target plan.
13. According to the company's SOP, carry out continuous vocational training for team member, set performance appraisal objectives, and complete the performance appraisal, so as to ensure that team members can have a good career development plan.
14. To be responsible for the organization and coordination of the business within the department of medical affairs.
15. Participate in the project bidding of clients, establish good communication and cooperation with clients, and provide professional consulting services for clients.
16. Responsible for assigned tasks of drafting or/and updating SOP of medical affairs department.
17. Other activities/tasks assigned by supervisor.
1. Ph.D. in Medical Science, More than 3 years clinical experience in oncology or chronic disease therapeutic area.
2. Or master degree major in medical science, More than 7 years clinical experience in oncology or chronic disease therapeutic area.
3. Be familiar with the key points of clinical trials and relevant policies and regulations.
4. Excellent ability of communication and execution, team spirit.
5. Leadership, analytical, and organizational skills preferred.
6. Languages: Excellent written and read English. Excellent oral English are preferred.