The Life Science Research Center offers a staff of highly trained scientists and technicians, and state of the art facilities to support our clients’ non-clinical research programs. We use a multidisciplinary integrated approach to provide critical solutions for our pharmaceuticals, biotech, agrichemical, industrial, and government clients.
The Inhalation Toxicologist, functions as a subject matter expert within the organization and, as a Study Director focuses on Inhalation Toxicology, has oversight of the scientific elements of projects to ensure successful implementation and/or study completion of non-clinical studies. The individual filling this position must be knowledgeable of emerging trends and may contribute to and influence best practices within the discipline. The individual will analyze and report results to our clients, provides scientific instruction to other members of the project team, and collaborate with other senior members of the staff on projects/research. The individual is responsible for the organization, management, and business performance of the projects they will assigned
Serves as Study Director on inhalation toxicology studies. May also be assigned to biodistribution, pharmacokinetic, and related studies. As a study director, you will ensure study execution, client engagement, and deliverables upon study completion.
Provides nonclinical expertise to a cross-functional project team.
Partners with business development and project management to generate proposals and costings for new work.
Works with internal functional areas to ensure all studies are performed in a quality, timely, and scientific manner.
Drafts protocols, amendments, departmental notifications, and study comments forms, ensuring correct grammar, punctuation, consistency in format and style, and adherence to regulatory requirements and contract language.
Follows GLP and other appropriate regulatory (e.g., OECD, ICH) requirements to ensure all experimental data, are accurately recorded and verified.
Authors, updates, and/or reviews area-specific SOP's, ensuring that SOP's reflect current practices.
Manages studies within time and budget constraints.
Participates in continual improvement initiatives.
THE FOLLOWING IS REQUIRED
Bachelor’s degree in life sciences related field with 6 years of experience or master’s degree in related field with 4 years of experience or PhD with 1 years of experience; or an equivalent combination of education and or experience in a related field.
Experience running Inhalation Toxicology studies.
Work within a GLP or similarly regulated environment.
Excellent writing and oral communication skills.
Experience in the preparation and review of regulatory documents including writing the nonclinical safety assessment portion of regulatory documents.
Proven ability to manage multiple projects/tasks at one time.
Experience creating and presenting scientific presentation and publications.
Able and willing to work in a biosafety level 2 (BSL2) environment and wear appropriate PPE.
Role will require immunization with FDA licensed vaccines and Investigational New Drugs (IND) recommended for persons at risk to occupational exposure of biological agents.
Requires participation in random drug screening.
THE FOLLOWING IS DESIRED
Diplomate of the American Board of Toxicology certified OR DABT eligible.