Job Description

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 Summary

A Research Scientist 1 - Safety Assessment serving as a study director (SD) in Ocular Toxicology is responsible for overseeing study conduct of preclinical biodistribution and toxicology that include assessing dose range finding and safety studies assigned by test facility management (TFM) within safety assessment; overseeing protocols/study plans; coordinating with technical teams for execution of studies, including establishing study schedules, verifying that standard operating procedures (SOPs) are available and adhered to, overseeing data recording and reporting, and verifying that regulatory requirements/expectations are met. The individual in this role interprets preclinical toxicity studies, evaluates and prepares reports from the data collected during these studies, communicates with sponsor representatives, and initiates contact with potential clients. May be involved with development of new technologies/procedures. 

Essential Functions:

• Design, write, review and edit study plans/protocols, amendments and study schedules that define and schedule all study activities.
• Oversee and coordinate study procedures.
• Verify that projects are performed according to SOPs and good laboratory practices (GLP) regulations.
• Write, review and edit draft or final reports that document all study related procedures and results.
• Communicate with sponsors on study related business.
• Oversee and coordinate study conduct (protocol development, technical guidance, and reporting).
• Assist in study planning, scheduling, and execution under the supervision of Sr. Scientist(s)/Scientific Manager.
• Host client visits and telephone/video conferences.
• Assists with mentoring less experienced staff and may assist with training of scientific/senior scientific associates as needed.
• Provides advice to clients and technical teams.
• May assist with proposal development.
• Develop an area of expertise.
• Other duties as assigned.

Job Qualifications

Qualifications (Knowledge, Experience, Skills and Abilities required to accomplish the essential functions) include but are not limited to:

• Masters’s degree or equivalent in Toxicology or a related discipline with prior CRO experience with ocular toxicology studies; PhD/PharmD/DVM degree or equivalent preferred with 2 or more years of related industry experience; postdoctoral experience with research involving ocular indications such as glaucoma, wet and dry AMD, anterior segment indications will be highly desirable.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Familiarity with preclinical ocular studies involving cell and gene therapy, knowledge and hands-on experience with cell culture, molecular biology techniques, histology, immunohistochemistry, and pathology is a plus
• Success in this role requires familiarity with: study/project costs and impact of changes, local regulations and GLPs as they relate to primary area of focus, study process from proposal to report, quality assurance (QA)/quality control (QC) processes, IACUC process, the SD role in animal welfare, effective communication with veterinary staff and internal/external clients in a manner that generates confidence and builds trust, and communication with technical supervisor and Scientific Manager on issues of staffing and equipment.
• Animal experience preferred.
• Strong communications skills, verbally and in writing at all levels inside and outside the organization.
• Basic familiarity with Microsoft Office Suite.
• Computer skills, commensurate with Essential Functions, including the ability to learn a validated system.
• Ability to work extended hours beyond normal work schedule to include, but not limited to evenings, weekends, extended shifts, and/or extra shifts; sometimes on short notice.
• Ability to work under specific time constraints.

The pay for this position is $84 - 95k/year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. 

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.

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