Associate Director, Medical Review & Data Innovation

Alexion Pharmaceuticals; Województwo mazowieckie; On-site; PLN 420,000 - 660,000; Full time

Job summary

Alexion Pharmaceuticals is seeking an Associate Director, Medical Review to lead the Medical Monitoring Unit. The role focuses on strategic development, data review, and technology-enabled improvements across clinical trials. Collaboration with leadership and cross-functional teams is essential to drive quality and efficiency.

The position emphasizes strong analytical skills, leadership, and experience with data systems and regulatory standards in a world-class biotech environment.

Qualifications

• Minimum bachelor’s degree in life science or related discipline.
• Three years of experience in the Biotech/Pharma/CRO industry or equivalent.
• Knowledge of ICH/GCP guidelines and clinical study processes.

Responsibilities

• Provide strategic assessment for Medical Monitoring strategy at study level.
• Lead standardization of work, processes, and tools.
• Explore automation to improve Medical Monitoring processes and systems.
• Oversee data review for safety and efficacy across trials and studies.
• Support trial execution, including data collection, site feasibility, and monitoring.
• Prepare study-related documents and regulatory submissions where needed.
• Mentor and coach staff to ensure professional development.
• Collaborate with cross-functional teams to advance tools, standards, and frameworks.

Skills

Leadership

Data analysis

Clinical data review

Stakeholder management

Automation

Cross-functional collaboration

Communication

Mentoring

Education

Bachelor's degree in life science

Tools

JReview

JMP Clinical

Spotfire

Python

R

SAS

Job description

Alexion Pharmaceuticals is seeking an Associate Director, Medical Review to lead the Medical Monitoring Unit. The role focuses on strategic development, data review, and technology-enabled improvements across clinical trials. Collaboration with leadership and cross-functional teams is essential to drive quality and efficiency.

The position emphasizes strong analytical skills, leadership, and experience with data systems and regulatory standards in a world-class biotech environment.