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Study Director I - General Toxicology

Charles River Laboratories, Inc.

Mattawan, MI • On-site

$85K - $88K/yr

Full-time

Medical, Retirement, PTO

Posted 4 days ago

Charles River Laboratories rating

8.4

Company rating: 8.4 out of 10

Based on 94 frontline employees who took The Breakroom Quiz

23rd of 86 rated pharmaceutical

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 Overview

We are seeking an experienced Research Scientist I for our General Toxicology Study Director Team in Mattawan MI.

A Research Scientist I - Safety Assessment serving as a study director (SD) is responsible for overseeing study conduct of preclinical efficacy and/or toxicology 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.

The pay range for this position is $85,000 to $88,000/yr USD. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Job Description
  • Function as an independent SD, working on studies/programs of basic to moderate complexity. See detailed role and responsibilities of Study Director below:
  • 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.
Minimum Requirements
  • Bachelor’s degree or equivalent in Toxicology or a related discipline; Master’s/PhD/PharmD/DVM/MD degree or equivalent preferred; with 2 or more years of related industry experience.
  • Data interpretation of in-vivo toxicology studies preferred.
  • Overseen or conducted in-vivo toxicology studies preferred.
  • Experience in understanding and implementation of US FDA guidance documents in relation to preclinical testing preferred.
  • 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.
  • 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.
  • Must be authorized to work in the United States without a sponsor visa, now or in the future.

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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About Charles River

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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 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 86% of the drugs approved by the FDA in 2021.

Industry

Scientific research and development services

Company size

10,000+ Employees

Headquarters location

Wilmington, MA, US

Year founded

1947

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