Study Director II, Toxicology

Inotiv•Mount Vernon, IN

About The Position

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. 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. 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! Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training. At Inotiv, our people are our greatest asset. We are committed to equality, opportunity, and diversity, and treating our colleagues with the dignity and respect they deserve. We strive to ensure that our people achieve their full potential, and that they enjoy a rewarding career with us. Introduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match. We’re looking for people who will help us grow and support our shared purpose: to help our clients discover and develop life-changing therapies for people around the world. As a leading contract research organization (CRO), Inotiv supports discovery and nonclinical development through investigational new drug (IND) and beyond. By leveraging our deep expertise and scientific capabilities, we help you increase efficiency, improve data, and reduce the cost of taking new drugs to market. By providing critical research models and related services, we help researchers realize the full potential of their R&D projects, all while working together to build a healthier and safer world. We hope you consider our opportunities and a future with Inotiv!

Requirements

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
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

Responsibilities

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
Perform duties of a Study Director