Director/Senior Medical Sciences (Medical Monitoring)

The primary objective for our Medical Director/Senior Medical Sciences is to provide input into the design and conduct of clinical trials, reviewing and/or generating key study documents (such as medical monitoring and safety management plans, treatment manuals, etc.), assessing and interpreting safety data, and contributing to investigator, other site staff and clinical study team training. Be readily available to advise on assigned clinical trial related medical questions or problems during the conduct of the trial. Reviewing and analyzing the eligibility of participants per inclusion/exclusion requirements of a clinical trial. Reviewing all adverse events to look for trends or risks, review all serious adverse events (SAEs), including review of the narrative, investigators’ assessment on causality, and applicable regulatory reporting. Providing review of study protocols and on-going medical oversight of clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed. Ensuring activities related to Severe Adverse Events (SAEs) are conducted in accordance with applicable SOP’s and regulations. Consulting with internal and external stakeholders in the development of clinical trial design and conduct including drafting of protocols and amendments. Developing and/or reviewing operational, medical monitoring, and safety plans for studies. Leading and/or participating in scientific and medical training to other team members and outside clients, investigators, and other site staff as it pertains to assigned studies. Generating safety related documents, such as medical monitoring reports and the safety database, to ensure that the reporting of SAEs is current and complete. Writing and/or reviewing Safety Narratives, Investigator Letters, and other safety documentation for site-reported safety events.