Research Scientist II, Toxicology

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform.

In return, we’ll help you build a career that you can feel passionate about.

Job Overview Serve as a scientist in the conduct of assigned nonclinical toxicology research studies of moderate to high complexity, to include study management, interpretation and reporting of study data, and assuring the regulatory compliance of these projects.

Job Description Designs and/or executes toxicology testing strategies and studies. Provides guidance to Sponsors regarding study design and study endpoints. Writes study protocols and plans. Leads and is responsible for all aspects of the study including in-life, data review and interpretation, communication of results to Sponsors, study updates to the Sponsor, and the draft and final reports. Ensures that all Principal Investigators, Individual Scientists, and all key study personnel are held accountable for the various study components.

Provides advisory functions to clients designing a program or experiment, dealing with specific dataset interpretation, or when appropriate answering questions from regulatory authorities.

Function independently as a study director in the direction and execution of assigned studies in compliance with GLP regulations as they apply to the conduct of nonclinical research.

Participate in and coordinate all phases of the study planning process with appropriate departments.

Review, interpret, integrate, and present data on assigned studies with minimal assistance.

Function independently as contact for the planning and execution of sponsor interaction related to assigned studies, including proposal management and study scheduling, conduct and reporting.

Assist in the oversight of the laboratory and mentor technical staff in areas such as protocol interpretation, method development and refinement, study-related problem resolution, and technique validation.

Provide technical and scientific guidance to the research staff.

Education and Experience Requirements

Education:

Bachelor's degree (B.S./B.A.) or equivalent in a scientific related discipline. Related Master's degree (M.S./M.A.) or PhD/DVM preferred.

Experience:

Minimum of 8 to 9 years related experience in the contract research, academic, or pharmaceutical industry.

An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

Certification/Licensure:
Certification as appropriate for specialty preferred.

Other:
Understanding of regulatory requirements of study types assigned, as well as Testing Facility SOPs and the Good Laboratory Practices (GLPs), as appropriate. Demonstrate leadership skills as they pertain to intra- and interdepartmental initiatives, Sponsor interactions, and business development. Effective written and verbal communication skills. Ability to handle multiple projects, prioritize work and meet deadlines. Proficiency in the use of standard software including Microsoft Excel, Word, Powerpoint, etc.

and with standard laboratory calculations.

Work Environment and

Physical Requirements While performing the duties of this job, the employee is regularly required to talk, hear and work/ type at a computer.

Specific vision abilities required by this job include close vision and the ability to adjust focus.

General office working conditions, the noise level in the work environment is…