Columbia, MO
Posted:

Job Description

Senior Study Director/ Toxicologist
Preclinical/ Nonclinical Drug Development

 

We are a growing mid-size organization with multiple sites looking for an accomplished Senior Study Director for our Toxicology division to assist with the growth we are experiencing and have plans to continue. 

Say Goodbye to the bureaucracy and the administrative aspects of large cumbersome organizations and say Hello to the Science

As a Senior Study Director, you will be responsible for participating in the design of non-clinical / preclinical in vivo studies as well as providing the scientific oversight of the study. The study director will direct and participate in the planning, organization, conduct and interpretation of animal research according to the regulations, protocols, standards and guidelines such as  USDA, FDA, GLP, GCP, etc.  Be responsible for monitoring studies and providing updates to both client sponsors and senior management.  Ensure that the employees are performing the study according to protocols and Standard Operating Procedures (SOPs)

These studies will involve standard laboratory animal species (mice, rats, NHP, swine) across typical test article types (Vaccines, Bio-pharmaceuticals, Small Molecules).

This role will encompass multiple site studies and coordination thereof. 

  • Serve as Study Director and participate in research projects including protocol development, preparation and administration of test article, collecting and processing samples or tissues from subjects. 
  • Plan an outline of research procedures to be followed during the course of the experiment. Writing protocols and reports as well as reviewing study schedules. 
  • Communicate with clients regularly regarding updates, amendments, deviations, study results etc. 
  • Assist in ensuring that personnel allocated to performing research activities for their studies have a clear understanding of the research protocol, activities to be performed, and are properly trained to conduct the procedures. 
  • Maintaining and completing multiple projects simultaneously
  • Developing Protocols
  • Communicating with staff, management, and clients/sponsors
  • Analysis, interpretation, and reporting of data from non-clinical studies. 
  • Manage the conduct of study activities in compliance with the protocol, amendments, and facility SOPs
  • May also assist in the further development of SOPs, training materials, and policies. 
  • Proactive recognition, documentation, and resolution of any issues affecting the conduct of non-clinical studies. 
  • Maintain knowledge of FDA and other regulatory guidelines
  • Work with the appropriate individuals to design and approve the study protocols
  • Perform other duties directed by the Director of Toxicology to meet client needs. 
  • Develop and Maintan SOPs, assist in developing training materials as needed, mentor junior Study Directors [Senior Study Director and Principal Study Director]
  • Provide Input on company policies, procedures, and documentation necessary to maintain compliance with the GLP guidelines and to ensure scientific rigor in the studies conducted on site [Principal Study Director]

 

Experience, Education, and Specialized Knowledge and Skills: 

Study Director 

  • Education and Experience
  • BS/BA in a relevant scientific field with 2 -4 years experience – OR – Masters Degree in a relevant scientific field with 2 years experience

Senior Study Director

  • Education and Experience
  • BS/BA in a relevant scientific field with 6-8 years of related drug development experience – OR – PhD in a relevant scientific field with 4 years related experience 
Principal Scientist – Principal Study Director
  • Education and Experience
  • BS/BA in a relevant scientific field with 16 years of related drug development experience – OR – PhD in a relevant scientific field with 12 years related experience 

 

This role will offer relocation and will also offer partial Work From Home ability (cannot work remote from another state) 

 

DABT or Board eligible preferred

Essential Skills include: leadership, good organizational skills, knowledge of an experience with GLP (Good Laboratory Practices), AAALAC and USDA guidelines, experience using computer applications.

 

 

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