Study Director 2 - Drug Safety Evaluation (DSE)

Industry: Pharmaceuticals & Biotech


Less than 5 years

Posted 24 days ago

Job Summary

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.


· 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.