Key Responsibilities

• Work as primary Medical Monitor for assigned clinical trials which includes being readily available to advise on trial related medical questions or problems during the conduct of the trial.
• Review and analysis of eligibility per inclusion/exclusion requirements of a clinical trial.
• This may include assessment of diagnostic imaging per protocol requirements
• 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.
• Provide 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.
• Consult with internal and external stakeholders and experts to assist in the development and assisting in the design and conduct of clinical trials including the drafting of protocols and amendments.
• Assist with business development activities, including participation in bid defenses, and the development of business proposals as it pertains to Medical Affairs.
• Develop and/or review operational, medical monitoring, and safety plans for awarded studies.
• Assist in the study feasibility process by generating/reviewing feasibility questionnaires, identifying patient pathways, defining standard of care, and support site identification and selection.
• Lead and/or participate in scientific and medical training to other Vial team members and outside clients, investigators, and other site staff as it pertains to assigned studies.
• This may include travel, attendance, and presentation at investigator meetings, symposiums, and/or conferences
• Monitor patient safety by acting as a medical monitor and/or in the development and conduct of a DSMB.
• Ensure activities related to SAEs are conducted in accordance with applicable SOP’s and regulations.
• Generate safety related documents, such as medical monitoring reports and the safety database, to ensure that the reporting of SAEs is current and complete.
• Write and/or review Safety Narratives, Investigator Letters, and other safety documentation for site-reported safety events.
• 24/7 emergency coverage for safety-related matters

Who You Are

• Doctor of Medicine (MD) in Ophthalmology with retina specialty with a minimum of 5 years direct experience in the pharmaceutical industry, preferably in a medical monitoring role, required.
• Relevant work experience in medical monitoring and/or pharmacovigilance and/or drug safety experience in a CRO, pharmaceutical, or clinical trial environment required.
• Proficient with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.