Job Overview

We are seeking an experienced Research Scientist I to join our Safety Assessment team in Mattawan, MI.

A Research Scientist I - Safety Assessment serving as a study director (SD) is responsible for overseeing study conduct of preclinical Safety Pharmacology 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 $86,000 - 89,000 USD/annually. Please note that hourly rates 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.

Qualifications• 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. 2+ years experience as a Study Director and/or Safety Pharmacology experience 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.

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.

We9re 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.

For more information, please visit www.criver.com.

234435