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.
Charles River Horsham, our Pennsylvania location, was opened in 1979 under the name of Argus Research Laboratories and became part of Charles River in 2001. The Horsham site specializes in Reproductive and Developmental Toxicology (DART), Juvenile Toxicology, Neurobehavioral Toxicology, Phototoxicology, Gene Therapy, and Vaccine safety testing. The internationally-recognized scientists at this facility have unmatched expertise in specialty toxicology, and the facility is rapidly developing recognition for its capabilities in gene therapies for the pediatric population. Horsham is ideally located just north of historic Philadelphia, Pennsylvania and its many historic attractions, sports activities, colleges and universities, concerts and shopping. We are just a couple of hours drive to Pennsylvania’s mountains and the beaches of New Jersey, Delaware, and Maryland and, via car or Amtrak, to New York City and Washington, D.C.
Study Director/Scientist position overseeing study conduct of preclinical efficacy and/or toxicology studies within the Safety Assessment division of Charles River Laboratories, Inc. The Study Director/Scientist has overall responsibility for the technical conduct of studies according to FDA or other applicable guidelines and Good Laboratory Practice (GLP) regulations. Primary responsibilities include but are not limited to protocol preparation and approval, study oversight, documentation of protocol deviations and amendments, reviewing data, ensuring accurate incorporation of results and conclusions into the study report, working with the Sponsors to address study-specific changes, ensuring archiving of all study reports, and meeting study timelines and quality standards.
- Function as an independent Study Director in accordance with the applicable GLPs.
- Under the supervision of Sr. Scientist/Scientific Manager, designs, writes, reviews and edits study plans/protocols, amendments that define and schedule all study activities.
- Oversees and coordinates all aspects of study conduct, whether performed within the department or by service departments.
- Assist in study planning, scheduling, and execution.
- Ensures that projects are performed according to SOPs and GLP regulations and is aware of appropriate regulations, guidelines and guidances.
- Writes, reviews and edits draft or final reports that document all study-related procedures and results.
- Promptly communicates with Sponsors on study-related business.
- Understands the study process from proposal to report.
- 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.
- 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.
- Provides advice to clients and to technical teams.
- May attend scientific meetings, conferences, and training courses to enhance job and professional skills.
Education: Minimum of Bachelor’s degree (BA/BS) or equivalent in Toxicology or related discipline. Prefer Master’s (MA/MS), Doctorate (PhD), PharmD, DVM, or MD degree or equivalent.
Experience: Generally 2 to 3 years related industry experience, preferred. An equivalent combination of education and experience may be accepted. May represent an entry level position for individual without experience, but holding a Doctorate (PhD), PharmD, DVM or MD degree or equivalent in Toxicology, Pharmacology, or related discipline.
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 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.
About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 17,000 employees within 90 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2019, revenue increased to $2.62 billion.
At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of ~85% of the drugs approved by the FDA in 2019.
For more information, please visit www.criver.com.
To apply, please visit https://career4.successfactors.com/sfcareer/jobreqcareer?jobId=113393&company=charlesrivP
Equal Employment Opportunity
Charles River Laboratories, Inc. is an Equal Opportunity Employer - M/F/Disabled/Vet
Nearest Major Market: Philadelphia
Job Segment: Research Scientist, Scientific, Toxicology, Biotech, Science, Engineering, Research