Medical Director / Senior Medical Director, Clinical Development
Core
Provide medical oversight for global late-stage clinical studies of an investigational gamma secretase inhibitor for desmoid tumors, ensuring patient safety and protocol implementation.
Role type
Senior Medical Director / Medical Monitor (Clinical Development)
Builds
Global clinical trials for targeted oncology therapies (gamma secretase inhibitors, ADCs)
Domain
Oncology / Clinical Development
Required skills
Medical monitoring, patient safety oversight, protocol implementation, adverse event evaluation, regulatory interaction, investigator engagement
Preferred skills
Experience with gamma secretase inhibitors, antibody-drug conjugates, desmoid tumors
Technologies
Clinical trial management systems, safety databases
Responsibilities
Serve as primary Medical Monitor for global clinical studies; Provide ongoing medical review of safety, efficacy, and eligibility data; Evaluate and assess serious adverse events and emerging safety signals; Collaborate with Pharmacovigilance for risk management; Participate in Safety Review Committees and Data Monitoring Committees; Ensure subject safety remains the primary consideration in study conduct; Provide medical oversight of study execution from initiation through database lock; Support protocol development and amendments; Review protocol deviations and endpoint assessments; Partner with Clinical Operations to address site-level medical questions and enrollment challenges; Assist with development of study training materials; Serve as primary medical contact for investigators.
