Assembly Biosciences, Inc.

Medical Director

• Design and execute clinical development plans and protocols for clinical trials in viral diseases and other indications
• Collaborate with functional teams during program implementation, study start-up, execution, closeout, data analysis/reporting, and NDA/MAA/ROW filings
• Serve as medical monitor for company-sponsored clinical trials, providing real-time medical oversight to investigators and sites
• Develop and maintain study-level Medical Monitoring Plans and medical data review plans
• Oversee CRO medical monitors and ensure consistent application of protocols and monitoring guidelines
• Perform ongoing medical review of safety and laboratory data, including target-organ safety signals
• Partner with Drug Safety/Pharmacovigilance on SAE and SUSAR assessment, causality, and benefit-risk evaluation
• Participate in the Safety Review Team and serve as clinical interface to independent Data Monitoring Committees
• Contribute to safety surveillance plans, study-level risk management, and stopping/pausing criteria
• Provide scientific and clinical guidance to Clinical Trials Management, Biometrics, Regulatory, and Project Management
• Serve as clinical point of contact for senior management and senior-level internal and external teams
• Provide medical and clinical input to informed consent forms, case report forms, statistical analysis plans, and data edit checks
• Author protocols, clinical study reports, and regulatory filings
• Manage clinical research components of regulatory documents, IND annual reports/DSURs, IND safety reports, Investigator Brochures, and development plans
• Support responses to health authority and ethics committee/IRB questions and inspection readiness
• Coordinate ongoing data collection, internal analysis, data listings, summary tables, study results, and scientific presentations
• Present scientific and clinical study information at investigator, internal, and external meetings
• Engage key opinion leaders and external experts in virology, infectious diseases, and relevant therapeutic areas
• Mentor and provide medical guidance to clinical science and clinical operations staff
• Participate in evaluating business development opportunities

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Director, Clinical Development