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Senior Research Scientist (Study Director) - Toxicology

Charles River Laboratories International Inc (CRL)

Horsham, PA, US, 19044

Senior Research Scientist (Study Director) - Toxicology Req ID #:  145378 Location: 

Horsham, PA, US, 19044 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.

QUALIFICATIONS:

•    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. 

 

 

IMPORTANT: 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. 

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 18,000 employees within 100 facilities in over 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. 

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 >80% of the drugs approved by the FDA for the past 3 years.

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet.

 

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

 

For more information, please visit www.criver.com.

Nearest Major Market: Philadelphia

Job Segment: Toxicology, Scientific, Biotech, Manager, Research Scientist, Science, Engineering, Management

Job posted: 2021-12-28

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