Study Director I - General Toxicology

About the role

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 the conduct of preclinical efficacy and/or toxicology studies assigned by test facility management within safety assessment; overseeing protocols/study plans; coordinating with technical teams for study execution, including establishing study schedules, verifying that 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, communicates with sponsor representatives, and initiates contact with potential clients. May be involved with development of new technologies/procedures.

Responsibilities

• 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 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.
• Assist with mentoring less experienced staff and may assist with training of scientific/senior scientific associates as needed.
• Provide advice to clients and technical teams.
• May assist with proposal development.
• Develop an area of expertise.
• Other duties as assigned.

Requirements

• Bachelor’s degree or equivalent in Toxicology or a related discipline; Master’s/PhD/PharmD/DVM/MD degree or equivalent preferred.
• 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.
• Familiarity with study/project costs and impact of changes, local regulations and GLPs, study process from proposal to report, QA/QC processes, IACUC process, the SD role in animal welfare, effective communication with veterinary staff and internal/external clients, and communication with technical supervisor and Scientific Manager on staffing and equipment.
• Strong written and verbal communication skills 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 evenings, weekends, extended shifts, and/or extra shifts; sometimes on short notice, and under specific time constraints.
• Must be authorized to work in the United States without a sponsor visa, now or in the future.

Pay

The pay range for this position is $85,000 to $88,000 per year USD. Salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.