• Assist in design, author and/or review clinical study synopses, protocols, amendments, study reports and other study-related documents. • Act as a medical monitor for assigned study. • Discuss study design with investigators and key opinion leaders. • Provide clinical input for clinical protocol monitoring guidelines and analysis plans. • Drive clinical database design, data collection and cleaning and oversees clinical interpretation of study data. • Track emerging efficacy and safety profile of drugs in on-going clinical trials; inform Clinical Development team of changes in the efficacy/safety and/or risk benefit profiles as they occur. • Provide input and/or prepare clinical sections of regulatory documents (e.g., INDs, IND annual reports, Investigator’s Brochures, CRFs, Informed Consent forms, Statistical Analysis Plans, Data Management edit check specs, clinical supplies package diagrams and labeling). • Lead or assist in the development of publications – abstracts, manuscripts, slides, etc. • In collaboration with team members (e.g., Clinical Operations, Data Management), assist in identifying / evaluating / monitoring vendors, monitoring clinical trial conduct/status. • Assist in database finalization, reviews of study results, results interpretation and CSR’s. • Assist in planning and presentation conduct of investigator meetings and Advisory Boards. • Oversee and manage vendor activities/deliverables as appropriate. • Present study results, as appropriate, to medical/scientific community at meetings and in published format.