Research Scientist I, Study Director

Job Summary

We are seeking a Research Scientist I, Study Director for our In Vivo team at our Safety Assessment site located in Spencerville, OH. 

Basic Summary: 

Responsible for overseeing study conduct of preclinical efficacy and/or toxicology studies assigned by TFM within safety assessment.  Responsible for protocols/study plans, coordinates with technical teams to allow appropriate execution of the study, including establishing study schedules, ensuring adequate Standard Operating Procedures are available and adhered to, oversee adequate data recording and reporting, and ensures regulatory requirements/expectations are met for the assigned study(ies).  Overall interpretation of preclinical toxicity studies, evaluation and preparation of reports from the data collected during these studies, communication with sponsor representatives, initiating contact with potential clients will be required, Familiarity with study costs and impact of changes will be required.  May be involved with development of new technologies/procedures.   

Essential Duties and Responsibilities: (The fundamental Competencies/Skills & Responsibilities of the role (products and services provided/results accomplished) include, but are not limited to, those listed:

• Function as an independent Study Director in accordance with the applicable Good Laboratory Practices (GLPs) (see detailed role and responsibilities of Study Director below).
• Understands local regulations and GLP’s as they relate to primary area of focus.
• Understands the study process from proposal to report.
• Oversees and coordinates study conduct (protocol development, technical guidance, and reporting).
• Assists in study planning, scheduling, and execution under the supervision of Sr. Scientist(s)/Scientific Manager.
• Host client visits and telephone/video conferences.
• Effectively communicates with internal and external clients in a manner that generates confidence and builds trust.
• Works on studies/programs of basic to moderate complexity.
• Gains experience and begins to develop an area of expertise.
• Basic knowledge of Quality Assurance (QA)/Quality Control (QC) process.
• Interacts with veterinary staff, understands the IACUC process, and understands the Study Director role in animal welfare.
• Assists with mentoring of less experienced staff and may assist with training of scientific/senior scientific associate, as needed.
• Provides advice to clients and to technical teams.
• Understands importance of overall project costs and communicates with the technical supervisor as well as the Scientific Manager on issues of staffing and equipment.
• May participate in proposal development.
• May attend scientific meetings, conferences and training courses to enhance job and professional skills.

The pay range for this position is 85-95K. Please note that starting salaries vary based on factors including, but not limited to, experience, skills, education, certifications, and location

Job Qualifications

(Knowledge, Experience, Skills and Abilities required to accomplish the essential functions) include but are not limited to:

• Education:  Minimum of a Bachelor’s degree (BA/BS) or equivalent in Toxicology or related discipline.  Prefer Master’s (MA/MS), Doctorate (PhD), PharmD, DVM, or MD degree or equivalent.
• Experience:  Minimum 2 to 3 years related industry experience. 
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Certification/Licensure:  None

Physical Demands:

• Regularly operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer.
• Must occasionally move about inside the office to access file cabinets, office machinery, etc.
• Regularly provides information to and receives information from/through various technologies, media, sources and contacts. Must be able to accurately exchange accurate information in these situations.
• The employee must frequently operate a passenger vehicle
• The employee must occasionally lift and/or move up to 10 pounds.

Work Environment:

• General office working conditions.
• The noise level in the work environment is usually quiet.
• While performing the duties of this job, the employee may be exposed to animal-related allergens.
• Laboratory and vivarium environment, as required.

Comments:

• This position may require domestic and international travels.