Sr. Manager, Translational Modeling

Role: Senior Manager, Translational Modeling, leading mechanistic modeling efforts in drug discovery and early development, primarily for biologics and protein therapeutics. Responsibilities: develop and implement PBPK, PK/PD, QSP, and pathway models; guide model-based decision-making; integrate diverse data sources; collaborate with cross-functional teams (DMPK, toxicology, bioanalytics, biology, clinical pharmacology); author regulatory documentation (IND/NDA/BLA); promote best practices and evaluate emerging methodologies including AI/ML. Requirements: PhD in systems biology, engineering, biochemistry, or related field; at least 5 years of pharma/biotech experience with expertise in translational modeling, especially PBPK and QSP; proficiency in scientific computing (preferably Matlab/SimBiology); extensive model development experience impacting program success; strong understanding of drug development from discovery through early clinical phases; excellent communication skills. Preferred: experience across multiple therapeutic areas, modalities, delivery routes; contribution to regulatory submissions; experience with AI/ML; scientific publications; external collaborations. High-Value: biologics, protein therapeutics, mechanistic MIDD approaches, early-stage clinical development support, cross-functional collaboration, regulatory documentation. Work setup and travel details are not specified.