Associate Director, Medical Review & Data Strategy

Alexion Pharma Spain S.L.; Warszawa; Hybrid; PLN 420,000 - 640,000; Full time

Job summary

Alexion Warsaw is seeking an Associate Director, Medical Review to lead the medical review activities within the Medical Monitoring Unit. This role oversees review of efficacy and safety data, collaborates with MMU leadership, and drives process improvements across tools and systems.

The position requires strong leadership, English communication, and a solid background in clinical data review and monitoring.

Qualifications

• Minimum bachelor's degree in life science or related discipline.
• Minimum three years of experience in clinical studies in Biotech/Pharma/CRO.
• Knowledge of ICH/GCP Guidelines.
• Experience with data review tools and medical monitoring processes.

Responsibilities

• Provide strategic assessment with enterprise mindset for Medical Monitoring strategy at study level.
• Lead best practices, optimization, and standardization of processes, tools, and workflows.
• Explore technologies to automate Medical Monitoring processes and tooling.
• Oversee safety and efficacy data review during clinical trials; support data collection activities.

Skills

Medical Review

Data analysis

Leadership

Stakeholder mgmt

Project management

Education

Bachelor's degree in life science

MD or equivalent

Tools

JReview

JMP Clinical

Spotfire

Python

R

Job description

Alexion Warsaw is seeking an Associate Director, Medical Review to lead the medical review activities within the Medical Monitoring Unit. This role oversees review of efficacy and safety data, collaborates with MMU leadership, and drives process improvements across tools and systems.

The position requires strong leadership, English communication, and a solid background in clinical data review and monitoring.