Associate Director, Clinical Pharmacology and Pharmacometrics

Responsibilities

• Develop and apply QSP models using MATLAB to characterize target engagement and PK/PD relationships
• Conduct competitive landscape and benchmarking analyses using competitor PK/PD data
• Lead quantitative dose-selection strategy for first-in-human studies
• Build and apply population pharmacokinetic (PopPK) models in NONMEM using SAD and MAD data
• Perform exposure-response (E-R) analyses for autoimmune and inflammation indications
• Conduct bioequivalence and relative bioavailability analyses for formulation and device bridging
• Partner with cross-functional teams including Clinical Development, Regulatory Affairs, and CMC
• Oversee CRO pharmacometricians and contribute to methodology improvements

Requirements

• Ph.D. in Pharmacometrics, Pharmaceutical Sciences, Clinical Pharmacology, Bioengineering, or Systems Biology
• Minimum 6-8 years of relevant industry experience in clinical pharmacology/pharmacometrics
• Demonstrated proficiency in QSP model development using MATLAB
• Strong hands-on expertise in population PK/PD modeling using NONMEM
• Proficiency in R for pharmacometric data analysis and visualization
• Experience translating nonclinical and early clinical data into human dose projections
• Experience with bioequivalence/relative bioavailability modeling
• Experience authoring pharmacometric sections of regulatory submissions

Preferred Qualifications

• Prior experience supporting subcutaneous biologic formulation/device lifecycle programs
• Experience with competitive intelligence modeling and MIDD approaches
• Prior direct interaction with FDA/EMA on clinical pharmacology matters
• People management or matrixed team leadership experience

About the Company

Dianthus Therapeutics is developing potentially best-in-class therapies for patients living with severe autoimmune diseases, focusing on high selectivity and improved potency for subcutaneous administration.