医学总监

该职位来源于猎聘 Participate in all stages of the clinical trial development process including: feasibility assessments; protocol design; CRF design; investigational site selection; generation of clinical study reports  Acts as Medical Monitor / Advisor for assigned trials or programmes  Exhibit and transmit the highest ethical standards in the management of clinical trial programs and client liaison  Provide medical support to the clinical project teams  Provide therapeutic area training to the clinical project teams and investigator teams  Take responsibility for the medical management of adverse events and serious adverse events in accordance with project related guidance  Review SAE narratives and takes responsibility for the writing of narratives associated with critical events as defined by each project  Oversee medical aspects of the risk management and risk mitigation strategies  Supports Pharmacovigilance is relevant steps of case processing and periodic reporting  Provide medical input to relevant Pharmacovigilance activities throughout the product lifecycle  Take responsibility for and initiates the medical review of: protocols; CRFs; adverse events; clinical study reports; data management and statistical tables and listings; audit reports  Write assigned sections of clinical study reports

Primary Responsibilities

• Develop product clinical development strategy and executive plan under appropriate departmental supervision.
• Skilled in organizing and writing materials related to medical clinical trials of CDE communication meetings, attending face-to-face meetings and communicating with CDE experts when necessary.
• Establish good communication relationship with medical experts in key fields, and close communication about research programs.
• Draft, review, and QC of clinical documents to ensure compliance of documentation to GCP, SOPs.
• Development medical supervision 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 monitoring of SAE and programme deviation.
• Work closely with CO, RA, BD, PV and other departments, provide advice, support and assistance according to project needs (select of lead

PI/ Participate in project meetings and protocol discussion).

• Serve as primary technical contact with client under appropriate departmental supervision.
• Provide medical professional guidance to subordinates.

Qualification:

• Ph.D. in Medical Science, More than 1 years clinical experience in oncology or chronic disease therapeutic area.
• Or master degree major in medical science, More than 3 years clinical experience in oncology or chronic disease therapeutic area.
• Or bachelor degree in medicine, More than 5 years clinical experience in oncology or chronic disease therapeutic area.
• Be familiar with the key points of clinical trials and relevant policies and regulations.
• Languages: Excellent written and read English Excellent oral

English are preferred.