Director, Pharmacometrics & Quantitative Medicine

Job description

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 . We have an excellent opportunity for a Director, 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. Expected Base Salary Range: $225,000 - $262,000 The actual salary will be based on the selected candidate’s qualifications, including skills, competencies, education and experience. Xencor offers a competitive total rewards package including 401k match, healthcare coverage, ESPP and a broad range of other benefits. In addition, this position will be eligible for an annual bonus and equity grant. For more information, please see . Americans with Disabilities Act (ADA) Statement The Company will provide reasonable accommodations (such as a qualified sign language interpreter or other personal assistance) with the application process upon your request as required to comply with applicable laws. If you have a disability and require assistance in this application process, please contact . To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. Equal Employment Opportunity (EEO) Statement The Company is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender or gender identity, national origin, disability status, protected veteran status or any other characteristic protected by state or federal law. Xencor does not accept profiles or resumes from recruiting vendors without a binding written agreement. Any unsolicited submission of services and or resumes in no way creates an obligation or duty by Xencor, implied or otherwise.