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.
We are currently looking for a Medical Director (Rheumatology – Lupus Scoring) for our Central Review Services team. The role can be work from home or based in any of our US PRA offices.
The Medical Director (Rheumatology – Lupus Scoring)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.
Primarily we are looking for physicians who are interested in the Lupus field and want to review assessment data from subjects with lupus, support sites, provide study training and support clients with study setup, protocol review and their scientific program.
In addition we would also like to see that the candidates have interest in Medical Monitoring so that we can assign them more flexibly depending on the work load and backlog of study work.
You are:
An expert in your field with an affinity to lead and inspire.
Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have the following:
- Medical degree and formal Rheumatology fellowship training & board certification
- CRO, biotech or pharmaceutical experience including project leadership and interaction with therapeutic and medical experts preferred
- Excellent verbal and written communication
- Ability to present and train global audiences
- Ability to work independently with minimal supervision
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
Job Type: Full-time