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Toxicology Senior Director

Responsibilities:

The Senior Study Director of Toxicology is responsible for all aspects of the toxicology program conducted at the test facility.  Duties include, but are not limited to, supervision of and participation in the following:

  • Protocol preparation, data sheet preparation, IACUC submissions, study execution, data collection, and documentation, report preparation and assuring protocol, SOP, and regulatory compliance for Sponsor studies;.
  • The Study Director represents the single point of study control;
  • The position requires direct communications with Sponsors and an ability to work across functional units internally to plan, execute, and complete testing programs that meet Sponsor requirements;
  • Other duties include in-life resource planning, maintaining current testing procedures, program development, performance monitoring, annual budget planning, resource management;
  • The Senior Director of Toxicology will represent WuXi AppTec and its safety testing programs externally and will interface between senior management and the toxicology department internally.
  • Design and execute nonclinical toxicology study protocols, analyze and interpret the results, and write a final report of the findings;
  • Monitor all aspects of a study;
  • Assure on-time delivery of high quality reports at the completion of each study;
  • Provide leadership, technical support, expertise for preclinical study design, analysis of data, and interpretation of results for all of the safety studies as necessary;
  • Provide timely updates of departmental activities to WuXi AppTec senior management;
  • Provide leadership and training to Toxicology technical staff as required;
  • Train study directors and assume study director responsibilities when required;
  • Remain current on appropriate company SOPs (standard operating procedures), GLP (Good Laboratory Practice) regulations, and regulatory guidelines.
  • Represent WuXi AppTec at appropriate internal and external scientific/regulatory meetings;
  • Provide input on equipment purchases intended for use in the toxicology program.

Basic Qualifications

  • Master degree in toxicology or related fields (eg. medicine, veterinary medicine, physiology, molecular biology) and at least 10 years’ experience in preclinical research
  • Board Certification in Toxicology (Diplomate, American Board of Toxicology, DABT) is desirable
  • Experience in a Preclinical Contract Research Organization is desirable;
  • Experience in the directing/monitoring of toxicology studies for medical device and /or biopharmaceutical and pharmaceutical industry; 
  • Knowledge of Good Laboratory Practice (GLP) and relevant FDA, ICH and/or ISO guidelines is essential
  • Detail orientation, excellent written and oral communication skills, effective leadership skills/working well with people, diverse, adaptable, independent, and reliable
  • Knowledge of computer software programs, such as Microsoft® products (Word, Excel, PowerPoint, Outlook);
  • Fluency in English

Any Applications,Pls contact: tony_li@wuxiapptec.com;global_talent@wuxiapptec.com