Suzanne Lukac

About Suzanne Lukac

I am a life sciences leader with experience in Clinical Development, Operations, and Quality, with a specialty in Risk-Based Quality Management (RBQM), inspection readiness, and process improvement. Throughout my career, I’ve built and led cross-functional teams, implemented innovative data visualization and monitoring solutions, and driven operational excellence across early- and late-stage studies in oncology, infectious diseases, vaccines, and neurology.Currently, I serve as Director, Global Development Transformation at Amgen, where I lead strategy for process compliance to support enterprise-level transformation initiatives. Previously, I’ve held leadership roles at Pfizer, Seagen, Merck, and other global organizations, consistently focusing on enhancing study quality, enabling technology-driven solutions, and fostering collaboration between stakeholders worldwide.My passion lies in connecting science, technology, and people to deliver better outcomes in clinical research. I thrive on building strategies that are not only compliant but also innovative and forward-looking—ensuring teams are prepared, patients are protected, and trials deliver meaningful results.

Experience

1. Global Development Transformation Lead

   Amgen

   Jul 2025 — Present

Education

• Temple University

  Bachelor of Science (B.Sc.), Molecular Biology

• Lehigh University

  Molecular Biology

Skills

• Clinical Trials
• Clinical Development
• Medical Writing
• Oncology
• Drug Development
• Pharmaceutical Industry
• Therapeutic Areas
• Infectious Diseases
• Protocol
• Clinical Operations
• Clinical Monitoring
• Regulatory Submissions
• Ctms
• Clinical Research
• Vaccines
• Gcp
• Fda
• Sop
• Immunology
• Neuroscience
• Clinical Study Design
• Biomarkers
• Data Management
• Risk-Based Monitoring
• Clinical Quality
• Risk Assessment
• Quality Management
• U.s. Food and Drug Administration (Fda)
• Standard Operating Procedure (Sop)