The Medical Reviewer/Director of Therapeutic Expertise will work within a multidisciplinary team to support client deliverables, including grading services for efficacy indices, business development, communication and training.
PRA’s Central Review Services team, unique in the CRO industry, offers lupus-specific
expertise in protocol and endpoint design, standardized central medical review and
grading, efficacy data cleaning, and investigator and site training. Since 2006, this
physician-led team has supported multiple global Phases I-III clinical studies in over 4,500
subjects with generalized SLE and lupus-related diseases, including nephritis and arthritis.
The team is solely focused on delivering independent, centralized endpoint data
evaluation, grading, and data management for SLE clinical and laboratory endpoints
including BILAG; SLEDAI; SLEDAI Flare Index; SLICC; and other assessment tools. This
central review process produces a higher level of accuracy and decreased variability that
is essential in endpoint measurement and analysis.
The Medical Reviewer/Director of Therapeutic Expertise will work within a
multidisciplinary team to support client deliverables, including grading services for
efficacy indices, business development, communication and training. Extensive
experience with global clinical trials is desired. This should include but not be limited to
study start-up activities including site selection and set up, investigator meeting
experience, study conduct phase, data analysis and close out activities. The ability to
travel domestically and internationally and to present to global audiences is strongly
Medical Degree (MD) required
Therapeutic expertise in Rheumatology is preferred but other complex medical
indications will be considered
Substantial CRO, biotech or pharmaceutical experience including project
leadership and interaction with therapeutic and medical experts required
Excellent verbal and written communication
Ability to present and train global audiences
Ability to work independently with minimal supervision
Ability to travel domestically and internationally
To qualify, applicants must be legally authorized to work in the United States, and should
not require, now or in the future, sponsorship for employment visa status. PRA is an
EEO/AA employer and is committed to providing opportunities to minorities, women,
veterans and individuals with disabilities.