高级医学经理/总监

该职位来源于猎聘 1. Medical Research and Development Role：

• Contribute to the clinical development strategy and the clinical development plan with corresponding molecules from clinical perspective.
• Design study protocol for corresponding molecules including early phase I, II and phase III clinical studies in collaboration with internal team, external expertise and the lead investigator.
• Closely working with clinical development team in the clinical studies preparation, conduction, result interpretation.
• Take medical lead and work with development team to develop/review/write/approve clinical science documents, including but not limited to Informed Consent Form, Case Report Form, Case Report Form instructions, data management relevant documents, SAP, MP, study risk management plan, drug supply plan, clinical pharmacology related activities (PK/PD report, modeling, simulation plans etc), IB and DSUR.
• Provide initial and ongoing medical training to operation teams and investigators to ensure the high standards of the clinical trials.
• Ensure study quality during operation period, such as monitor and review critical data and process in clinical trials, including but not limited to identify and evaluate the protocol deviations.
• Lead medical relevant tasks on study committee (steering committee, adjudication committee, safety monitoring committee etc).
• Take medical lead in IND/NDA/BLA activities. Collaborate with regulatory and other teams to complete and submit regulatory filing and other regulatory documentation including dossier preparation. Participate in communications with health authority.
• Prepare or review the study reports and CTD for NDA/BLA and respond to authority’s inquiries in regard with medical related.
• Prepare or review abstracts, posters, and content for scientific events in domestic and/or international academic platform etc.
• Review safety data and provide medical support and judgment to ensure high standards of clinical safety. 2. Other important Responsibilities：
• Participate and support the research, IITs, in/out licensing of new targets or drugs in other therapeutic areas led by business development.
• Interact with external experts from healthcare organization and/or institutions. (e.g., Center of Drug Evaluation, Advisory Committee, Key Opinion Lead, Medical Scientific Society).