Director, Pharmacometrics & Quantitative Medicine

Introduction:

Xencor is a public, clinical-stage biopharmaceutical company located in the Los Angeles area (Pasadena) and in San Diego. Our focus is developing high-potential XmAb® bispecific T-cell engagers and additional engineered drug candidates that leverage our differentiated technology platforms, and we are advancing our pipeline toward clinical proof-of-concept decisions. Our goal is to create high-impact therapeutics for patients with cancer and other serious diseases. More than 20 XmAb drug candidates engineered with our technology are in clinical development, and three XmAb medicines have been marketed by partners. For more information, please visit www.xencor.com. We have an excellent opportunity for aDirector, Pharmacometrics & Quantitative Medicine to join our team.

This position can be hybrid with 2 days a week onsite from either our Pasadena or San Diego office or remote with candidate available during PST working hours.

Summary:

Responsible for pre-clinical and clinical investigation of pharmacokinetic vs. pharmacodynamic, safety, efficacy and other related biomarker relationships for novel T-cell engagers and immune-based therapeutics.

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
• Build models for characterizing tumor-growth dynamics and inform expected longer term outcomes like DoR, PFS and OS based on early clinical data
• Explore novel methods like AI/ML to be able 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
• Collaborate 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. The responsibilities may include, but are not limited to recruiting, training, communicating job expectations, appraising and managing job performance, delivering feedback and coaching, and providing career development planning and opportunities
• Performs other duties as assigned.

Education/Experience/Skills:

Position requires a 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.

Position also requires:

• 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)
• Ability to demonstrate competencies applicable for job based on Xencor’s Leadership Competency Model. Ability to effectively manage others through coaching and supervision, in accordance with company policies and practices
• Ensures employee performance meets the organization’s expectations for conduct, productivity, quality, continuous improvement, and goal accomplishment.

Occasional travel may be required, including travel between Xencor’s Pasadena and San Diego offices. Work for this position is generally performed at Xencor’s worksite and requires full-time commitment.