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 Life Scientist, functions as a subject matter expert within the organization and, as a study director, 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 be assigned.
In the role of Subject Matter Expert (SME) interfaces with client's scientific staff as appropriate.
Provides nonclinical expertise to a cross-functional project team.
Serves as Study Director on toxicology, biodistribution, pharmacokinetic, and related studies to ensure study execution, client engagement, and deliverables upon study completion.
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.
Work with senior management to shape the current offerings of nonclinical pharmacology including toxicology and ADME.
Work with senior management to develop new technologies and services.
Helps support preparation of reports and regulatory documents for IND and NDA submissions.
THE FOLLOWING IS REQUIRED
PhD degree in life sciences or DVM, with 2+ years prior experience.
Expertise in design, execution, interpretation of non-clinical studies with a focus of ADME and PK/PD.
Knowledge of nonclinical data packages needed to support first in human studies, clinical development and product registration.
Work within a GLP or similarly regulated environment.
Experience in pharmaceutical toxicology.
Knowledge of drug development and understanding of life cycle management concepts and interdependencies with the overall development process.
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.
Must be a US citizen with the ability and willingness to obtain security clearance including DOJ Security Risk Assessment (SRA) approval.
Ability to obtain/maintain certification in Chemical Personnel Reliability Program (NACLC required) and/or Biological Personnel Reliability Program, and Biological Suitability Assessment Program.
Able and willing to work in a biosafety level 2 (BSL2) and/or 3 (BSL3) (biocontainment) 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.
US citizenship is required.
THE FOLLOWING IS DESIRED
Diplomate of the American Board of Toxicology certified OR DABT eligible - if not currently certified, candidate will be required to become board certified within two years of hire date.