Medical Director Clinical Development
CurrentCross-departmental team lead responsible for the design, implementation, analysis and reporting of the clinical development program and clinical trials for specified candidate vaccines and/or monoclonal antibodies including HIV, tuberculosis (TB) and emerging infectious disease (EID) candidatesMaintained communication concerning study progress, safety assessment and scientific results by working with Principal Investigators, Safety Monitoring Committee Members, clinical study team members, and medical representatives of vaccine developers for assigned projects• Evaluated and followed all adverse events to resolution, evaluated causality, ensured safety of trial participants/patients, maintained communication with Principal Investigators, clinical site teams and safety monitoring committee members concerning participant/patient safety and study progressOrganized relevant medical information, writing of clinical narrative, completion of CIOMs reports as needed for serious adverse eventsCreated/Revised Investigator Brochures, Periodic Benefit Risk Evaluation Reports, and other pertinent documents for all assigned studiesProvided oversight of the Medical Writing service assignments, as well as adherence to project writing timelines
