A Study Director 2, is responsible for the overall planning and conduct of the non-clinical investigations in accordance with applicable regulatory guidelines and contemporary scientific practice. The person in this role primarily concentrates on internal/external communications, scientific expertise, and regulatory compliance, as well as other essential functions, such as business development with a focus on customer service. The ultimate goal of the Study Director 2 is to operate effectively within the essential functions of the role, particularly with respect to client communication and scientific expertise, while developing and maintaining a viable client base.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
· Study Management: Performs as a Study Director in the conduct of study performance as described under GLP standards.
· Scientific Expertise and Regulatory Compliance: Interprets, evaluates, and reports studies, and provides peer reviews; develops protocols, remains knowledgeable of advances in field of expertise, and verifies conduct of preclinical investigations, in accordance with applicable regulatory guidelines and contemporary scientific practice.
· Communications: Communicates, in writing and verbally, with external and internal customers; consults and negotiates with customers.
· Business Development: Consults and advises Sponsors on design, pricing, and scheduling of studies; maintains market and business development with potential and future clients with a focus on customer service; establishes on-going repeat
The following are minimum requirements related to the Study Director 2 position:
· PhD in relevant field and 0-4 years of relevant experience; or
· Bachelor's/Master's degree in relevant field and 3 years as a Study Director.
· Experience will be considered between management and the candidate.
· Additional factors for consideration include but are not limited to: publications / presentations; continuing education credits; professional society memberships / positions (i.e., committees, education boards, etc.); certifications; showing good scientific judgment, and participation in company development projects.
· Basic familiarity with Microsoft Office Suite.
· Computer skills, commensurate with Essential Functions and including 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.