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Study Director

Employer
Inotiv
Location
West Lafayette, IN
Start date
Aug 11, 2022

View more

Discipline
Science/R&D, Pharmacology, Pharmacokinetics
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioMidwest
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Study Director-In Vivo DMPK

Inotiv is a growing contemporary drug discovery and development company where we “Play to Win” in an industry rich with opportunity. Together, we face challenges and together we win in the delivery of world-class drug discovery and development solutions that impact the health and well-being of people all over the world.  There’s an opportunity for everyone at all phases of a career, each individual’s unique skill set has an impact on the work we conduct. If you have the talent and desire to impact the quality of people’s lives, we have the career opportunities to make it happen.

Join us in embracing research and science to impact the health and well-being of people all over the world.

Job Summary

The Study Director for our West Lafayette, Indiana In Vivo team has overall responsibility for the design and technical conduct of in vivo pharmacokinetic and disposition (DMPK) studies, as well as for the interpretation, analysis, documentation, and reporting of results. Working in a team environment, you will support our clients in advancing their preclinical research for these critical discovery studies and enabling decisions for further development. 

Essential Duties and Responsibilities

  • Consulting with Inotiv clients on optimal study design to ensure appropriate use of research animals and achievement of study objectives
  • Responsible for all phases of protocol development 
  • Managing the conduct of study activities in compliance with the protocol, amendments/planned changes, and appropriate SOPs
  • Assuring that all experimental data, including observations of unanticipated responses of the test system, are accurately recorded and verified
  • Assuring that study requirements resulting in use of methods other than those normally used are brought to the attention of Management and that staff are appropriately trained
  • Consulting with Management to facilitate availability of resources prior to initiation of study activities and periodically during the project as needed
  • Coordination of appropriate communication mechanisms with the Sponsor
  • Interpret study data and author study reports in collaboration with Principal Scientists from other disciplines (bioanalytical, pharmacokinetics, metabolism, etc)
  • Follow SOPs and other applicable laboratory or company procedures and assure that any facility SOP or protocol deviations are documented in the study data package and detailed in the report as appropriate
  • Perform other duties as assigned

Skills and Abilities

  • Excellent organizational, written, and oral communication skills
  • An attitude for quality; detail-oriented
  • Demonstrate an understanding of and adhere to facility SOPs and Good Laboratory Practice Regulations (21CFR, Part 58) as they relate to study specific services provided, this job description, and general facility operations
  • A working knowledge and awareness of general laboratory procedures
  • Ability to use personal computer and various software programs
  • Ability to work independently
  • Interact with clients, other employees, and the community in a professional manner
  • Maintain confidential information
  • Support and participate in other company initiatives as directed
  • Ability to read, write, speak, and understand English
  • Demonstrate Inotiv Core Values and adhere to Code of Conduct

Education and Experience

  • B.S. and five years industry experience (drug metabolism and pharmocokinetics, pharmacology, or other related disciplines)
  • M.S. and three years industry experience
  • Ph.D. and 1-2 years industry experience 
  • Equivalent combination of related education and required work experience will be considered with management approval

Salary will be commensurate with experience and responsibilities. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K participation with company match, etc. 

 Inotiv is a proud equal opportunity employer and an E-Verify employer.


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