Senior Medical Director - Medical Monitoring

Role: Medical Monitor supporting clinical development of biopharma therapies for rare/end-stage diseases, including PAH, PH-ILD, and organ regeneration. Responsibilities: provide medical expertise during clinical trials, review protocols, safety data, SAEs, and study reports; ensure compliance with ICH GCP and regulatory standards; train internal/external teams; support safety monitoring activities, data interpretation, and study documentation. Requirements: MD, DO, or foreign equivalent; 7+ years in clinical monitoring or relevant medical practice with industry trial support; ability to independently make medical decisions; proficiency in Microsoft Office; experience in critical care, pulmonology, nephrology, or transplant medicine preferred. High-Value: supporting early/late-phase clinical trials for novel biologics or organ regeneration therapies; safety oversight in complex disease areas; remote or hybrid work in the US; emphasis on rare/serious diseases and innovative transplant medicine.