Bridgewater, NJ30+ days ago
p>• Board licensed MD (or equivalent foreign qualification) in Immunology • Minimum of 8-10 years of Clinical Development experience (pharma, CRO) in Immunology/Autoimmunity • Previous experience designing and developing phase 1-4 protocols • Therapeutic area experience preferred (demonstrable with 2 or more years relevant experience) • Demonstrates ability to analyze and interpret data, assess clinical relevance and present/report findings (e.g., ISS, ISE, competitor data, etc.) • Experience working on a matrix cross-functional clinical team • Previous project management/clinical operations experience desirable • Knowledge of statistics, data analysis and data interpretation • Experience with the operation aspects of clinical trials and related activities such as investigator meetings, DSMB's and GCP/ICH are necessary • Excellent written and oral communication skills • Organizational and cross functional collaboration skills • Proficient in Microsoft Office Suite of Programs. • Ensure CD contributions to trial-related documents such as the IBs, ICF, CRFs, CRF Completion Guidelines, Study Execution and Monitoring Plans, Clinical Data Review Plan, Clinical Database specifications, statistical analysis plan, the data management plan, the safety management plan, the medical monitoring plan, Clinical Study Report (CSR) etc.