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. Job 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, oversee 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.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Function as an independent Study Director in accordance with the applicable Good Laboratory Practices (GLPs) (see detailed role and responsibilities of Study Director below).
- Understands local regulations and GLP's as they relate to primary area of focus.
- Understands the study process from proposal to report.
- Oversees and coordinates study conduct (protocol development, technical guidance, and reporting).
- Assists in study planning, scheduling, and execution under the supervision of Sr. Scientist(s)/Scientific Manager.
- Host client visits and telephone/video conferences.
- Effectively communicates with internal and external clients in a manner that generates confidence and builds trust.
- Works on studies/programs of basic to moderate complexity.
- Gains experience and begins to develop an area of expertise.
- Basic knowledge of Quality Assurance (QA)/Quality Control (QC) process.
- Interacts with veterinary staff, understands the IACUC process, and understands the Study Director role in animal welfare.
- Assists with mentoring of less experienced staff and may assist with training of scientific/senior scientific associate, as needed.
- Provides advice to clients and to technical teams.
- Understands importance of overall project costs and communicates with the technical supervisor as well as the Scientific Manager on issues of staffing and equipment.
- May participate in proposal development.
- May attend scientific meetings, conferences and training courses to enhance job and professional skills.
Education: Bachelor's degree (BA/BS) or equivalent in Toxicology or related discipline - required. Prefer Master's (MA/MS), Doctorate (PhD), PharmD, DVM, or MD degree or equivalent.
Experience: Minimum 2 to 3 years related industry experience.
Certification/Licensure: NoneIMPORTANT: A resume is required to be considered for this position.
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.