Study Director III, Toxicology

Inotiv

$90K — $120K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree and 10 years or master's with 5 years, or PhD with 2 years in biological sciences.
  • Experience in laboratory animal work required.
  • Familiarity with cGMP, GLP, GCP, and OECD regulations.
  • Strong organizational skills and attention to detail.
  • Effective written and oral communication skills.

Responsibilities

  • Develop and oversee study protocols with team engagement.
  • Direct and supervise technical staff in compliance with standards.
  • Monitor study progress and report findings to sponsors.
  • Conduct literature searches to support project needs.
  • Assist in preparing scientific papers and presentations for publication.
  • Prepare interim reports based on study data in consultation with senior staff.
  • Ensure adherence to safety and regulatory practices.

Benefits

  • Health and dental coverage.
  • Short- and long-term disability options.
  • Paid time off and paid parental leave.
  • 401K retirement plan options.
Full Job Description
Performance requirements

Characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

General
  • Ability to read, write, speak, and understand English
  • Ability to read, write and understand oral and/or written instructions

Physical Activity
  • Ability to read, write and interpret scientific material
  • Manual dexterity to perform research functions, type and use office equipment
  • Ability to stand or sit for long period of time

Working Conditions
  • Frequent involvement with radiant/electrical energy, solvents, grease, oil, irritants, acids, bases, and other hazardous chemicals, electro-mechanical hazards, flammable materials, and biohazards. Due to exposure to hazardous biological materials (which may include HIV positive specimens), immunization to diseases may be a required
  • Will be exposed to animal dander, bites, scratches, etc., and material associated with animal husbandry
  • Able to wear latex gloves, dust musk and/or respirator, and safety glasses as required.
  • The noise level is usually moderate to loud requiring ear protection
  • Mantoux TB test with negative result is required


Tools, Equipment, & Other Resources Used
  • Various software applications sustained by a WindowsTM platform. (Excel, Word, PowerPoint, etc.)


Responsibilities and Duties
  • Responsible for all phases of protocol development; communicating with supervisory staff to establish a study schedule, the sponsor to finalize the protocol and the technical staff to coordinate study initiation
  • Direct and/or supervise the work of technical staff in accordance with the GLP's
  • Monitor the progress of studies and after consultation with senior staff, report the results to the sponsor
  • Participate in in-house training programs for the technical staff
  • Conduct literature and/or Internet searches in support of protocol or report preparation
  • With the assistance of senior staff, prepare posters and/or scientific paper that will contribute to the scientific reputation of Inotiv Evansville and the individual
  • In consultation with senior staff, prepare reports, papers and/or charts of study data for interim reports to the sponsor
  • Maintain knowledge of FDA and other regulatory guidelines that may affect protocol development
  • Inform the management of any issues affecting the conduct of preclinical studies, interaction with clients and/or generation of protocols and reports
  • Perform other duties as assigned
  • Maintain confidential information
  • Interact with the community and employees
  • Support and participate in other company initiatives as directed by management

Position Summary

Perform duties of a Study Director

Position Requirements

Education and experience
  • This position requires a bachelor's degree and 10 years of relevant experience, or a master's degree and 5 years relevant experience, or a doctoral degree in one of the biological sciences and at least 2 years relevant laboratory animal experience

Skills and Abilities
  • Good organizational skills
  • Ability to use a computer to compile and maintain databases for records and inventory, utilizing the appropriate software
  • Know and understand cGMP/GLP/GCP and OECD regulations, as applicable, with the ability to apply these practices daily
  • Ability to work independently
  • Good written and oral communication skills
  • Ability to adhere to all safety regulations and procedures
  • Ability to document analytical results


*This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience. The salary range will adjust along with the level of the role to match the person's relevant experience and/or education level.

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, and more!

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