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Study Director 2 - Drug Safety Evaluation (DSE)

Req ID #:  44628
Location: 

Mattawan, MI, US, 49071

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.

Job Summary

 

We are seeking an experienced Study Director 2 for the Study Directors - Drug Safety Evaluation (DSE) Team located in Mattawan, MI.


 

Study Director 2, is responsible for the overall planning and conduct of the non-clinical investigations in accordance with applicable regulatory guidelines and contemporary scientific practice. The person in this role primarily concentrates on internal/external communications, scientific expertise, and regulatory compliance, as well as other essential functions, such as business development with a focus on customer service. The ultimate goal of the Study Director 2 is to operate effectively within the essential functions of the role, particularly with respect to client communication and scientific expertise, while developing and maintaining a viable client base.


 

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:
 

· Study Management: Performs as a Study Director in the conduct of study performance as described under GLP standards.
· Scientific Expertise and Regulatory Compliance: Interprets, evaluates, and reports studies, and provides peer reviews; develops protocols, remains knowledgeable of advances in field of expertise, and verifies conduct of preclinical investigations, in accordance with applicable regulatory guidelines and contemporary scientific practice.
· Communications: Communicates, in writing and verbally, with external and internal customers; consults and negotiates with customers.
· Business Development: Consults and advises Sponsors on design, pricing, and scheduling of studies; maintains market and business development with potential and future clients with a focus on customer service; establishes on-going repeat

 

 

The following are minimum requirements related to the Study Director 2 position:


 

· PhD in relevant field and 0-4 years of relevant experience; or
· Bachelor’s/Master’s degree in relevant field and 3 years as a Study Director.
· Experience will be considered between management and the candidate.
· Additional factors for consideration include but are not limited to: publications / presentations; continuing education credits; professional society memberships / positions (i.e., committees, education boards, etc.); certifications; showing good scientific judgment, and participation in company development projects.
· Basic familiarity with Microsoft Office Suite.
· Computer skills, commensurate with Essential Functions and including 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.

 

 

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 14,000 employees within 80 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 2018, revenue increased by 22% to $2.27 billion from $1.86 billion in 2017.

 

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 2018.

 

Equal Employment Opportunity 

 

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


Nearest Major Market: Kalamazoo

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