Dr Schmelzer is a Senior Director in Certara with over 20 years of experience in modeling and drug development. A PhD-qualified pharmacologist and toxicologist by training, she has worked as a clinical pharmacologist in biotech companies and has provided drug development consultancy to many large and small organizations. During her career she has developed, executed and managed clinical pharmacology plans, quantitative modelling and regulatory strategies in specific populations for both small molecules and biologics.  Her projects reach across the drug development cycle (nonclinical, first in human through to approval). She has also led multi-functional project teams, and provided translational science leadership for projects in the early stages of clinical development involving novel mechanisms of action. She has extensive experience in translational PKPD, PBPK, C-QTc analysis, and Met ID across multiple therapeutic areas including cardiology, pulmonary, neuroscience, neuromuscular, and oncology.