The department of Global Scientific Affairs within PRA Business Unit “Early Development Services (EDS)”is responsible for providing clients and the internal organization with scientific support in the design, conduct and reporting of clinical development programs and the underlying individual clinical studies.
In order to do so, the department maintains intensive relationships with clients, the scientific community, regulators, key opinion leaders, and subcontractors such as specialty labs. The department advises internally and externally about program and study design, and research models. It monitors scientific and medical developments, and takes the lead to incorporate these in programs and supports their practical implementation. The department is a key function in PRA’s objective of ‘Leading with Science’.
The job role is to define and detail the drug development strategy, based on a well-crafted Target Product Profile as ultimate development goal. With a good understanding of the concepts of drug development over various therapeutic areas, he/she applies a wide range of clinical pharmacology, pharmacokinetic, and pharmacodynamic expertise to drug development programs, study protocols, and regulatory filing packages.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.