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
Responsible for overseeing study conduct of preclinical efficacy and/or toxicology studies assigned by TFM within safety assessment. Responsible for protocols/study plans, coordinate 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 ensure 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.
Job Description
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Function as an independent Study Director in accordance with the applicable Good Laboratory Practices (GLPs).
- Designs, writes, reviews and edits, as necessary, Study Plans, amendments and study schedules that define and schedule all study activities.
- Oversees and coordinates all aspects of study procedures, whether performed within the department or by service departments.
- Ensures that projects are performed according to Standard Operating Procedures and Good Laboratory Practice regulations and is aware of appropriate regulations, guidelines and guidances.
- Writes, reviews and edits, as necessary, draft or final reports that document all study related procedures and results.
- Prompt verbal or written communication with Sponsors on study related business.
- Understands 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 with support/guidance from Sr. Scientist(s) as needed.
- Effectively communicates with internal and external clients in a manner that generates confidence and builds trust.
- Works on studies/programs of basic complexity.
- Basic knowledge of Quality Assurance (QA)/Quality Control (QC) process.
- Experience handling laboratory animal data. Interacts with veterinary staff, understands the IACUC process, and understands the Study Director role in animal welfare.
- Gains familiarity with overall project costs and communicates with the technical supervisor as well as the Scientific Manager on issues of staffing and equipment.
- May attend scientific meetings, conferences and training courses to enhance job and professional skills.
The pay range for this position is between $88,000- 92,000/yr. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
Qualifications
QUALIFICATIONS:
Education: Minimum of a Bachelor’s degree (BA/BS) or equivalent in Toxicology, Pharmacology, or related discipline. Prefer Master’s (MA/MS), Doctorate (PhD), PharmD, DVM, or MD degree or equivalent. Five years' minimum relevant work experience is required for consideration. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
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 20,000 employees within 110 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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.
We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.
Equal Employment Opportunity
Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.
It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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.
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