Clinical Scientist

Job Summary

Leading the development of key clinical documents, the full-time Clinical Scientist will conduct clinical data reviews and provide input on protocol clarifications while working 100% remotely from Cambridge, MA.

Key responsibilities

• Develop and review clinical documents such as protocols, amendments, and clinical study reports
• Review clinical research forms, statistical analysis plans, and study manuals to ensure data integrity
• Perform routine and ad-hoc clinical data reviews and assist in the interpretation of data analyses

Required qualifications

• MS, PhD, or PharmD in a life science or related field
• Strong background in clinical research
• Recent and relevant experience as a Clinical Scientist
• Experience with systemic mastocytosis or other mast cell disorders
• Familiarity with regulatory submissions and responses to agencies such as the FDA and EMA