For 70 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.IMPORTANT:
In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process.
Please make sure work history and education are added correctly. Summary
Responsible for overseeing study conduct of preclinical efficacy and/or toxicology studies assigned by TFM within safety assessment. Responsible for protocols/study plans, coordinates with technical teams to allow appropriate execution of the study, including establishing study schedules, ensuring adequate Standard Operating Procedures are available and adhered to, oversees adequate data recording and reporting, and ensures regulatory requirements/expectations are met for the assigned study(ies). Overall interpretation of preclinical toxicity studies, evaluation and preparation of reports from the data collected during these studies, communication with sponsor representatives, initiating contact with potential clients will be required, Familiarity with study costs and impact of changes will be required. May be involved with development of new technologies/procedures.
Is an established key scientist in at least one area of expertise, with experience in different areas/disciplines. Responsibilities extended to include departmental, procedural or management of internal project(s) involvement and contributing to company growth (scientific and capabilities).**Related experience/industries - Toxicology, Vaccines, Gene Therapy, BSL 2, Study Director, General & Reproductive Toxicology, Bio-Medical Research** Responsibilities & Qualifications
- Functions as an independent Study Director in accordance with the applicable Good Laboratory Practices (GLPs).
- Where applicable, functions as Principal Investigator(PI)/Individual Scientist (IS).
- Understands the study process from proposal to report.
- Oversees and coordinates study conduct (protocol development, technical guidance, and reporting).
- Thoroughly understands local and international regulations and their application to client's products.
- Functions independently as contact for the planning and execution of sponsor interaction related to assigned studies.
- Effectively manages complex assignments within own discipline with considerable autonomy.
- Recognized internally as a subject matter expert.
- Host client visits and telephone/video conferences; can provide facility tours to Sponsors.
- Effectively communicates with internal and external clients in a manner that generates confidence and builds trust.
- Actively engages internal/external customers and demonstrates understanding of customers' needs, requirements, and expectations.
- Has the ability to consult with the client on a program and averts problems and practical limitations in advance.
- Has gained experience in more than one area/discipline.
- Thoroughly understands Quality Assurance (QA)/Quality Control (QC) process.
- Interacts with veterinary staff, and thoroughly understands the IACUC process and the Study Director role in animal welfare.
- Proactively provides developmental support, coaching, and/or assistance to other team members.
- May review reports of peers.
- Recognizes gaps and opportunities for improvements by keeping current with "State of the Art" techniques/procedures and assist in effectively transferring this information to and/or provides training to build intellectual capital within the corporation.
- Has direct impact on profitable revenue generation.
- May participate in the proposal management and bid development process.
- Collaborates on strategies and tactics for obtaining new business.
- Seeks ways to improve the delivery of products and services.
- Presents collaborative or independent research internally or externally; may publish data and/or scientific methodology in scientific publications. May participate in co-travel with commercial operations.
- Maintains involvement in various departmental/divisional projects and/or committees.
IMPORTANT: A resume is required to be considered for this position.
- Education: Bachelor's (BSc), Master's (MA/MSc), Doctorate (PhD), PharmD, DVM, or MD degree or equivalent in Toxicology, Pharmacology, or a related discipline.
- Experience: Generally 8 to 10 years related industry experience.
If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV.Vaccine Mandate
Charles River is a U.S. Federal Contractor. As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19 by December 8, 2021. Our main priority is the wellbeing, health, and safety of our people. We will be requiring proof of vaccination from all employees.
Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition (crrecruitment_US@crl.com) so that information can be provided about the accommodation process at Charles River.About Safety Assessment
Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 120 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.