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Inotiv · 2 weeks ago

Study Director I

Alice, TX

Full-time

Onsite

Mid Level

3+ years exp

Inotiv is a growing contemporary drug discovery and development company that focuses on delivering world-class solutions impacting health and well-being. The Study Director I will be responsible for executing studies, managing resources, and ensuring effective communication with sponsors throughout the project lifecycle.

BiopharmaLife ScienceMedical DevicePharmaceutical

Hiring Manager

Julie Melton, EdD

Responsibilities

For potential and awarded studies, work with management to determine available animals for use (inventory) and that studies are appropriately resourced (personnel)

Responsible for all phases of protocol development including approval prior to initiation of study activities

Establish appropriate communication mechanisms with the sponsor and ensure timely communication throughout the life cycle of the project

Review & approve data collection forms, formulation instructions, and formulation labels

Responsible for confirming that the study work schedule/calendar is consistent with study protocol

Manage the conduct of all study activities in alignment with the protocol and appropriate SOPs

Assure that all experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified

Assure that any unexpected events (including SOP or protocol deviations) that may affect the quality and integrity of the study are noted when they occur, management is informed, and corrective action is taken and documented

Report study results to the Sponsor after consultation with senior staff and in collaboration with key personnel/principal investigators

Ensure that study data and specimens are compiled, organized, inventoried, and archived at Inotiv or transferred to the archiving facility/sponsor prior to or upon completion of the report

Ensure that studies requiring methods other than those normally used are brought to the attention of staff and that staff are appropriately trained

Available to work weekends, holidays, and extended hours during the work week as assigned

Competency in the use of relevant computer systems and capable of assisting others with troubleshooting activities

Compliance with applicable USDA regulations, Animal Welfare Act, facility Animal Care and Use Committee requirements, and the Guide for Care and Use of Laboratory Animals

Responsible for monitoring compliance with all facility and company safety requirements including full compliance of PPE use and all safety policies and procedures

Qualification

In-vivo Study ExecutionStudy Direction ExperiencePharmacologyToxicologyPharmacokineticsProtocol DevelopmentCompliance MonitoringCommunication SkillsTeam CollaborationProblem Solving

Required

Bachelor's in Science

3-5 years' experience In-vivo Study Execution or Study Direction Experience in Pharmacology, Pharmacokinetics, or Toxicology

Available to work weekends, holidays, and extended hours during the work week as assigned

Competency in the use of relevant computer systems and capable of assisting others with troubleshooting activities

Compliance with applicable USDA regulations, Animal Welfare Act, facility Animal Care and Use Committee requirements, and the Guide for Care and Use of Laboratory Animals

Responsible for monitoring compliance with all facility and company safety requirements including full compliance of PPE use and all safety policies and procedures