Associate Director, Medical Review (Alexion)
Core
Lead the Medical Monitoring Unit to ensure completeness, robustness, and accuracy of clinical trial efficacy and safety data, supporting the determination of benefits and risks for rare disease treatments.
Role type
Senior IC Associate Director, Medical Review (Strategy & Operations)
Builds
Clinical trial data integrity, safety/efficacy assessments, and regulatory-ready medical reports for rare disease compounds.
Domain
Biopharmaceuticals / Clinical Research / Rare Diseases
Required skills
Clinical study design and conduct, Medical Monitoring strategy, Data analysis and interpretation, Risk-Based Monitoring, ICH/GCP guidelines, Medical coding (MedDRA, WHO DD), Stakeholder management, Team leadership and mentoring, Change management, Data visualization.
Preferred skills
Electronic data capture systems (JReview, JMP Clinical, Spotfire), Programming (Python, R, SAS), Cross-functional pharmaceutical development experience.
Technologies
JReview, JMP Clinical, Elluminate, Spotfire, Python, R, SAS, Microsoft Power Platform.
Responsibilities
Develop and execute Medical Monitoring strategy at the study level; Lead implementation of best practices and process optimization; Monitor, clean, and analyze safety and efficacy data to identify trends; Provide medical advice for risk assessment and mitigation; Mentor and coach Senior Medical Reviewers; Collaborate with technology functions to leverage automation and AI.
Seniority
Senior, hands-on IC with leadership responsibilities