• 招聘类型：社招
• 工作性质：全职

职位描述

Primary responsibilities include development strategy, planning, coordinating, monitoring, and management programs/projects for non-clinical safety evaluation; ensure all studies are executed and completed in accordance with corporate objectives, applicable regulations, guidelines and standard operating procedures; ensure all studies are deliverable on time with a high quality. The candidate is also required to be involved in the activity of internal product development and project management and to work both independently and in a multidisciplinary team setting to ensure timely completion of studies and all regulatory required documents.

• Conduct safety assessment for both small molecules and large molecules in the portfolio;
• Serve as a toxicology representative on assigned program, author nonclinical safety risk assessment documents for clinical programs and regulatory submissions;
• Work closely with Contract Research Organizations (CROs) on study protocols, ongoing status of studies, monitor critical phases as needed, and review key findings from studies;
• Review toxicology study reports to generate quality reports for regulatory submissions;
• Coach and develop team member and provide input to the other team members regarding the appropriate activities to be performed at the preclinical stage of development, for enhancing the timely integration and alignment of all functions;
• Identify and work with expert consultants depending on project specific needs;
• Effectively communicate with project teams, senior management, and regulatory agencies;
• Conduct due diligences and perform gap analyses on compounds for potential in-licensing opportunities;

任职条件

• Ph.D. or M.S. in life science, preferred pharmacology or toxicology background or related field with 5-10+ yrs. pharmaceutical/biotechnical industry experience;
• Board certification in toxicology (DABT) preferred;
• Minimum of 5 years hands-on expertise developing and executing preclinical study;
• Experience with all phases of pre-IND through Phase I/II/III programs and associated regulatory filings;
• Knowledge of drug development and life cycle management concepts and interdependencies with the overall development process;
• Working knowledge of global regulations and guidelines, including GLP, FDA, CFDA, ICH and OECD Guidelines, in the conduct of non-clinical studies and drug development;
• Excellent written and verbal communication skills in both English and Chinese;
• Excellent organization and management skills and proficient usage of Microsoft Office software;
• Experience working with small molecule and large molecule development;
• Experience writing the nonclinical safety assessment portions of an IND/CTA and IB.

职位要求

• 学历要求：博士及以上
• 工作经验：5年以上
• 外语要求：英文流利
• 管理经验：需要

公司福利

• 五险一金 
• 晋升空间 
• 法定节假日