Study Director - In Vivo at Charles River Laboratories, Inc. Stilwell, KS

Study Director - In Vivo (Stilwell, KS)

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.

A Study Director (SD) is responsible for overseeing study conduct of preclinical toxicokinetic/pharmacokinetic and toxicology studies; overseeing protocols/study plans; generation of IACUC protocols, coordinating with technical teams for execution of studies (internally and externally), including establishing study schedules, verifying that standard operating procedures (SOPs) are available and adhered to, overseeing data recording, and reporting, and verifying that client expectations are met.

The individual in this role independently interprets preclinical toxicity studies, evaluates and prepares data tables, data summaries, and reports from data collected during these studies. The Study Director communicates with sponsor monitors and representatives, initiates contact with potential clients, and interacts with CRL business development and client services. May be involved with development of new technologies/procedures and may be required to manage departmental and procedural projects.

See detailed role and responsibilities of Study Director below:

• Function as an independent SD, working in a fast‑paced environment on multiple studies/programs of moderate to difficult complexity.
• Design, write, review and edit study plans/protocols, amendments and study schedules that define and schedule all study activities.
• Oversee, coordinate, and manage study execution
  • Knowledge of formulations, clinical pathology, necropsy, biomarkers, histology, digital pathology, and bioanalysis.
• Verify that projects are performed according to the protocol and SOPs and excursions from study plan are addressed in a timely manner with the sponsor and internal teams.
• Write, review, and edit draft or final reports that document data and results in summary or condensed report format.
• Communicate with sponsors and CRL study support partners on study related business.
• Host client visits and telephone/video conferences; may assist with or lead facility tours with sponsors.
• Mentor less experienced staff and assist with training of research scientists and scientific coordinators.
• Provides advice to clients and technical teams; provide technical and scientific advice to research staff.
• Assist with proposal development and management under the supervision of Sr. Scientist/Scientific Manager.
• Develop expertise in other areas of speciality, such as specialized endpoints/study types.
• Assist with design, development, and/or performance of new procedures.
• May prepare abstracts for scientific publication, present collaborative or independent research internally or externally.
• Function as departmental representative for interdepartmental communications and initiatives as required.
• Possesses the qualities to solve problems, be a self‑starter, build networks, lead through support and lead by example.
• Other duties as assigned.

• Bachelor’s/Master’s/PhD/Pharm
  
  D/DVM/MD degree or equivalent in Toxicology, Pharmacology or a related discipline; with 5 or more years of related industry experience. Meets expectations related to essential duties and responsibilities of Research Scientist 1. May represent an entry level for individual with relevant Pharm
  
  D/DVM/MD degree or equivalent in Toxicology, Pharmacology or a related discipline.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Success in this role requires familiarity with: study/project costs and impact of changes, local and international regulations and GLPs as they relate to primary area of focus, study process from proposal to…