Study Director

Wuxi Apptec Saint Paul , MN 55102

Posted 1 week ago

Overview

Responsible for all aspects of custom studies performed within In-Life Services (ILS) at WuXi AppTec. The Study Director Customs serves as the interface between the St. Paul facility, Subcontract Laboratories and the Sponsor in terms of study planning, organization, execution, data analysis and final report construction. They will handle all resource planning and sponsor communication to complete the assigned studies on time.

Responsibilities

  • Responsible for all aspects of assigned custom projects

  • Maintains up-to-date knowledge of applicable guidelines and regulations

  • Performs data analysis, data interpretation and reporting of results

  • Ensures all aspects of the study are compliant with appropriate SOPs, GLPs, and applicable regulatory guidelines

  • Interacts with verbal & written communication with internal and external clients

  • Consult, advise on complex non-clinical or research/discovery experimental designs

  • Generate and maintain study and IACUC protocols

  • In charge of study initiation and closure

  • Manage and monitor multiple customized projects simultaneously

  • Frequently interact with technical staff to ensure study validity and protocol compliance

  • Develop expertise in applicable guidance interpretation

  • Identify and implement process improvements and best practices

  • Contributes scientific and technical expertise with high attention to detail

  • Demonstrates efficient and organized project management skills, effective communication skills, strategic and critical thinking as well as problem solving abilities

  • Thrives in a fast paced, multitasking environment, showing both leadership and team building skills

  • Ability to work in a team environment and independently, as required

  • Contributes to the overall operations and to the achievement of departmental goals

  • Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.

  • Thorough understanding of Good Laboratory Practices (GLP)

  • Other duties, as assigned

  • May be required to assist in other departments

Qualifications

Experience / Education

  • 3-5 years of relevant experience

  • PhD or MSc in toxicology, pharmacology, microbiology, biological sciences, or related field. Experience may be substituted for education (e.g., Bachelor's in biological sciences plus 5 or more years of relevant experience)

Knowledge / Skills / Abilities:

  • Prior Experience as a Study Director on GLP studies

  • Knowledge of biologics and/or medical device testing requirements

  • Experience with statistical analyses, preferred

  • Experience with small animal studies

  • Proficient in oral & written communication skills

  • Need to be able to read, write and understand English

  • Strong customer services skills

  • Experience in a regulated environment

  • Experience in technical writing or formal data presentation, preferred

  • Proficient in Microsoft (Excel, Word, Outlook)

Physical Requirements:

  • Must be able to work in an office environment with minimal noise conditions.

  • Must be able to work in lab setting with exposure to Animals / Chemicals

  • Must be able to wear appropriate PPE

  • Ability to sit for long periods of time

  • Clarity of sight

  • Inside working conditions

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability


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Study Director

Wuxi Apptec