Associate Director, Medical Review & Data Analytics

AstraZeneca plc; Warszawa; Hybrid; PLN 420,000 - 600,000; Full time

Job summary

Alexion is seeking an Associate Director, Medical Review for the Medical Monitoring Unit to oversee medical data review and trial safety analyses across studies. This role ensures data integrity and supports the portfolio with advanced tools and processes.

You will collaborate with the MM Leadership Team and Senior Scientists on strategy, oversee tool configuration and testing, and mentor staff while driving continuous professional development.

Qualifications

• Minimum bachelor’s degree in life science or related discipline; MD, MBBS, or equivalent for Associate Medical Director, Medical Monitor Scientist.
• Minimum three years of experience working on clinical studies in biotech/pharma/CRO.
• Understanding of the clinical study and drug development process.
• Knowledge of ICH/GCP Guidelines.
• Experience with data analysis and interpretation in clinical trials.

Responsibilities

• Provide strategic assessment with an enterprise mindset and accountability for the proactive development and execution of a Medical Monitoring strategy at the study level.
• Lead the implementation of best practices, optimization, and standardization of work, processes, and tools.
• Explore technologies to propose and lead automation and improvement of Medical Monitoring processes, tools, and systems.
• Lead the execution of clinical trials; monitor, clean, analyze, and review safety and efficacy data to identify trends and follow up as appropriate.
• Support the execution of clinical trials and data collection activities, guiding the clinical study team on-site training, oversight, patient recruitment, feasibility assessments and study closeout.
• Prepare clinical study documents, protocols, charters, statistical summaries, presentations, and regulatory sections.
• Participate in investigator meeting planning and execution; on-site initiation meetings.
• Provide medical advice for risk assessment and mitigation planning at the study level.
• Build networks and collaborate with technology functions and external partners to benefit Medical Monitoring.
• Lead and support functional and cross-functional improvements.

Skills

Analytical skills

Leadership

Communication

English proficiency

Project management

Education

Bachelor's degree in life science or related field

MD/MBBS or equivalent

Tools

Microsoft Excel

Microsoft Power Platform

JReview

R/Python (data analysis)

Job description

Alexion is seeking an Associate Director, Medical Review for the Medical Monitoring Unit to oversee medical data review and trial safety analyses across studies. This role ensures data integrity and supports the portfolio with advanced tools and processes.

You will collaborate with the MM Leadership Team and Senior Scientists on strategy, oversee tool configuration and testing, and mentor staff while driving continuous professional development.