Associate Director, Medical Review & Data Strategy

AstraZeneca plc; Województwo mazowieckie; Vor Ort; PLN 450.000 - 750.000; Vollzeit

Zusammenfassung

Alexion is seeking an Associate Director, Medical Review within the Medical Monitoring Unit to oversee data review, efficacy and safety analyses across clinical trials. You will collaborate with LT and senior scientists to implement strategy, optimize processes, and foster technical innovation.

You will lead cross-functional teams, mentor staff, and ensure high-quality data review while advancing tools and systems supporting pharmacovigilance and trial delivery.

Qualifikationen

• Minimum 3 years of experience working on clinical studies in Biotech/Pharma/CRO.
• Bachelor's degree in life science; MD/MBBS or equivalent for Associate Medical Director, Medical Monitor Scientist.
• Understanding of the clinical study and drug development process.
• Knowledge of ICH/GCP Guidelines.

Aufgaben

• 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, providing guidance to the clinical study team on-site training, oversight, patient recruitment, country and site feasibility assessments and selection.
• Support teams in preparing clinical study-related documents, including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents.
• Participate in investigator meeting planning and execution, including on-site initiation meetings.
• Provide medical advice for risk assessment and mitigation planning at the study level.
• Build networks, stakeholder relationships, and collaborate with technology functions across the organization and externally to benefit the Medical Monitoring Team.

Kenntnisse

Analytical skills

Leadership

Communication skills

Stakeholder management

Time management

Ausbildung

Bachelor's degree in life science

MD/MBBS or equivalent

Tools

JReview

JMP Clinical

Ellumin ate

Spotfire

Microsoft Power Platform

Jobbeschreibung

Alexion is seeking an Associate Director, Medical Review within the Medical Monitoring Unit to oversee data review, efficacy and safety analyses across clinical trials. You will collaborate with LT and senior scientists to implement strategy, optimize processes, and foster technical innovation.

You will lead cross-functional teams, mentor staff, and ensure high-quality data review while advancing tools and systems supporting pharmacovigilance and trial delivery.