Clinical Research Scientist IV needs 3 to 5 years clinical development experience in the pharmaceutical/biotech industry (clinical science, clinical operations, medical writing, etc.) experience.

Clinical Research Scientist IV requires:

• BS/MS/PhD in a related life science discipline


• Comprehensive understanding of the drug development process with early phase experience


• Prior oncology drug development experience preferred


• Experience in analysis and interpretation of clinical data (safety and efficacy) and a working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies


• Experience with interacting with medical monitors, development operations (clinical operations, data management, program management, regulatory affairs, medical writing) and clinical investigators


• Patient profile and data listing review experience


• Up to date in new clinical trial designs in oncology


• Strong analytical, problem-solving, and scientific writing skills


• Excellent oral and written communication skills and solid MS PowerPoint, MS Word, MS Excel, and analytical skills


• High level of organizational and project management skills


• Demonstrated ability to work independently in a matrix environment


• Demonstrated ability to prioritize and manage multiple tasks simultaneously


• Demonstrated ability to influence through collaboration


• Flexibility to accommodate changes in priorities and project needs

Clinical Research Scientist IV duties:

• Contribute to and/or lead the design of clinical studies in close collaboration with the Clinical Development Team


• Monitor protocol compliance including assessment of inclusion and exclusion criteria, patient medical history, concomitant medications, and key safety and efficacy measures


• In collaboration with the Medical Lead, review protocol deviations to identify cause and appropriate resolution


• In collaboration with the Medical Lead, perform regular medical review of individual subject data


• Collaborate with the Clinical Development Team on the review, analysis, and interpretation of study results, including exploratory endpoints and assuring appropriate data review and accurate data reporting