SUMMARY: Direct and participate in the planning, organization, and conduct of animal research according to the regulations, protocols, standards and guidelines, such as USDA, FDA, GLP, etc. Be responsible for technical supervision and/or support of research staff, client service and communications, monitoring of studies, and implementation of Good Laboratory Practice (GLP) regulations at SRC. Ensure that the employees are collecting and recording raw data and performing the study according to protocols, Standard Operating Procedures (SOPs) and GLP requirements. Assist in data collection and study procedures as needed.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:
1 Serve as Test Facility Management. o Designate a Study Director for each study prior to initiation, and replace the Study Director if necessary. o Responsible for implementation of GLP regulations at SRC. o Assure there is a quality assurance unit for regulated studies. o Assure that any deviations including GLP and protocols etc. are fully addressed. o Assure that test and control articles are appropriately tested.
2 Serve as Study Director for animal studies particularly in the areas of toxicology.
3 Responsible for timely, budget minded, and cost-effective completion of each study at SRC.
4 Develop, implement, and maintain company policies, SOPs, and documentation necessary for SRC to be compliant with federal, state, and local regulations. Lead the development of programs and processes for the performance, assessment, and marketing of dermatology related studies.
5 Serve also as a technical resource for toxicology issues and study designs.
6 Ensure appropriate training for research staff as related to study conduct.
7 Ensure proper communication within managed team/division both internally and externally.
8 Provide oversight for the conduct of all studies (non-regulatory and regulatory) to fulfill all regulatory requirements.
9 Provide an active role in the development, implementation, and maintenance of company policies, procedures.
Other duties may be assigned.
SUPERVISORY RESPONSIBILITIES: Management Tier 3: Top- Level for further information on tiers and authority please see Sinclair Book of Managers.
QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE: Exploratory and regulatory toxicology, direction of GLP and non-GLP studies involving rodents and non-rodents to support IND submission through NDA registration, experience in small molecules and biologicals, proficient at protocol and report generation, knowledgeable with all current regulatory guidance documents
CERTIFICATES, LICENSES, REGISTRATIONS: DABT
COMPETENCIES
- Problem Solving and Analysis
- Collaboration Skills
- Ethical Conduct and Integrity
- Project Management
- Customer Focus
- Communication and Active Listening
- Time Management and Organization
- Thoroughness
- Decision Making
- Leadership
PHYSICAL DEMANDS:
Sedentary work that primarily involves sitting/standing.
POSITION TYPE/EXPECTED HOURS OF WORK: This position is classified as Exempt; employees shall be paid an established salary and are expected to fulfill the duties of their position regardless of hours worked. Exempt employees are not eligible to receive overtime compensation. This position may require long hours and weekend work.
TRAVEL: Some travel is necessary for this position including conventions and off-site meetings. Travel is primarily local during the business day, although some out-of-area and overnight travel may be expected.
