Associate Director, Medical Review (Alexion)
Core
Lead the Medical Monitoring Unit to ensure completeness, robustness, consistency, and accuracy of critical medical data collected in clinical trials for rare disease treatments.
Role type
Senior IC Associate Director, Medical Review
Builds
Clinical trial data integrity, safety and efficacy analysis, and regulatory documentation for rare disease compounds.
Domain
Biopharmaceuticals / Clinical Trials / Rare Diseases
Required skills
Strategic planning, process optimization, automation and AI implementation, clinical data analysis, stakeholder management, team leadership, regulatory document preparation, risk assessment.
Preferred skills
Expertise in data analysis tools, visualization, and system configuration.
Responsibilities
Provide strategic assessment and execute Medical Monitoring strategy at the study level; Lead implementation of best practices and standardization of work processes; Explore and lead automation of Medical Monitoring processes; Monitor, clean, analyze, and review safety and efficacy data to identify trends; Support clinical trial execution including site feasibility and study closeout; Prepare clinical study documents including protocols and regulatory sections; Participate in investigator meeting planning; Provide medical advice for risk assessment and mitigation; Build networks with technology functions and external partners; Mentor and coach staff to ensure professional development.
Seniority
Senior, hands-on IC with leadership responsibilities