Director, Pharmacometrics & Quantitative Medicine

Primary Responsibilities

• Builds population PKPD models with covariates to inform dose selection and support regulatory interactions
• Conducts exposure-response analysis for safety and efficacy using multiple univariate and multivariate methods to inform the risk-benefit profile of XmAb drugs
• Builds models for characterizing tumor-growth dynamics and inform expected longer term outcomes like DoR, PFS and OS based on early clinical data
• Explores novel methods like AI/ML to discover hidden more complex relationships between endpoints of interest and relevant variables/covariates
• Integrates pharmacokinetic and pharmacology expertise to support preclinical and clinical activities for programs including T-cell engaging bispecifics for oncology or auto-immune and other immunology-based therapeutics for autoimmune diseases
• Collaborates cross-functionally with Research/Biometric/Bioinformatics/Clinical/Translational team to analyze and integrate PKPD and activity readouts to inform dose optimization, dose-escalation/expansion and RP2D/RP3D decisions
• Collaborates with research to inform candidate selection and implement techniques such as tumor growth inhibition models to preclinical efficacy studies
• Authors and reviews team documents including but not limited to statistical analysis plan, PKPD-ADA analysis plan, and regulatory submissions such as briefing documents, INDs, IB, clinical study reports, CTAs and NDAs
• Manages functional contractors and consulting organizations to support additional workload as needed
• Maintains current knowledge of the field and area(s) of scientific and technical expertise and development
• Adheres to all department and company-wide policies regarding conduct, performance and procedures
• Provides oversight and direction to direct and indirect reports, as applicable, in accordance with the organization’s policies and procedures

Qualifications

• Master’s degree in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Applied Mathematics, or a related discipline, plus a minimum of 10 years of related experience; a PhD with 7 years of related experience is preferred
• Experience managing external service providers and CRO’s with timely delivery of clear, accurate and well-written study findings also required
• Prior experience with T cell engagers is required
• Strong immunology and T-cell engager knowledge
• Proficiency with hands-on data analysis, modelling, and reporting using Rstudio, NonMem, Monolix, PUMAS or equivalent
• Strong knowledge of drug development and FDA and ICH guidance documents
• Excellent communication skills, including technical writing and verbal communications for productive cross-functional team interactions
• Strong knowledge and user competency in additional common software and data analysis packages (e.g., Microsoft Office Suite, SoftMax Pro, GraphPad Prism, JMP)