Serve as a scientist in the conduct of assigned nonclinical research studies of moderate to high complexity, to include study management, interpretation and reporting of study data, and assuring the regulatory compliance of these projects.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Function independently as a study director in the direction and execution of assigned studies in compliance with GLP regulations as they apply to the conduct of nonclinical research.
- Participate in and coordinate all phases of the study planning process with appropriate departments.
- Generate high-quality protocols, amendments, and reports appropriate for assigned studies.
- Review, interpret, integrate, and present data on assigned studies with minimal assistance.
- Function independently as contact for the planning and execution of sponsor interaction related to assigned studies, including proposal management and study scheduling, conduct and reporting.
- Assist in the oversight of the laboratory and mentor technical staff in areas such as protocol interpretation, method development and refinement, study-related problem resolution, and technique validation.
- Review reports for peers as needed.
- Provide technical and scientific guidance to the research staff.
- Attend scientific meetings, conferences and training courses to enhance job and professional skills.
- May supervise research and/or scientific staff, as appropriate for scope of responsibilities.
- Perform testing facility management duties for the site as delegated by senior management.
- Perform all other related duties as assigned.
- Education: Bachelor's degree (B.S./B.A.) or equivalent in a scientific related discipline. Related Master's degree (M.S./M.A.) or PhD/DVM preferred.
- Experience: Minimum of 8 to 9 years related experience in the contract research, academic, or pharmaceutical industry.
- 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.
- Other: Understanding of regulatory requirements of study types assigned, as well as Testing Facility SOPs and the Good Laboratory Practices (GLPs), as appropriate. Demonstrate leadership skills as they pertain to intra- and interdepartmental initiatives, Sponsor interactions, and business development. Effective written and verbal communication skills. Ability to handle multiple projects, prioritize work and meet deadlines. Proficiency in the use of standard software including Microsoft Excel, Word, PowerPoint, etc. and with standard laboratory calculations.
Equal Employment Opportunity
Our company is an Equal Opportunity Employer M/F/Disabled/Vet