Associate Director Drug Safety and Medical Monitor

This position is responsible for leading medical monitoring and medical review activities across all clinical trials, as well as overseeing patient safety surveillance and signal detection throughout clinical development programs. The individual collaborates closely with cross-functional teams, including Clinical Development, Clinical Operations, Biometrics, Regulatory, and Pharmacovigilance, to identify and resolve safety-related issues, ensure high-quality data handling, and support regulatory compliance. The role also contributes to the authoring and review of key regulatory and safety documents, including Clinical Tial Protocols (CTP), Informed Consent Forms (ICF), Investigator’s Brochures (IB), Clinical Study Reports (CSR), DSURs/PSURs/PBRERs, and other regulatory submissions.