Director, Clinical Pharmacology & Pharmacometrics

Xencor • Pasadena, CA

1d • $225,000 - $262,000 • Hybrid

About The Position

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 a Director, Clinical Pharmacology & Pharmacometrics to join our team.

This position is hybrid with 2 days a week onsite from either our Pasadena or San Diego office. This position has the potentially to be fully remote.

Summary:
Responsible for pre-clinical and clinical investigation of pharmacokinetic and pharmacodynamic (PK/PD) relationships for novel T-cell engagers and immune-based therapeutics.

Requirements

• 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.
• Strong immunology knowledge
• Proficiency with hands-on data analysis, modelling, and reporting using Phoenix WinNonLin, MATLAB, Rstudio, NonMem, Monolix, PUMAS or equivalent
• Strong knowledge and user competency in additional common software and data analysis packages (e.g., Microsoft Office Suite, SoftMax Pro, GraphPad Prism, JMP)
• 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
• 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.

Nice To Haves

• Strong immunology experience and prior experience with T cell engagers is preferred.

Responsibilities

• 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.
• Builds compartmental or non-compartmental models for PK including population PK models with covariates
• Conduct exposure response analyses for safety as well as efficacy to help support dose decisions within a trial and from one trial to the next
• Supports candidate selection and pre-IND activities including FIH dose selection
• 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
• Leads the execution of clinical pharmacology studies
• Authors and reviews documents including clinical protocols, and regulatory submissions such as briefing documents, INDs, IB, clinical study reports, CTAs and NDAs
• Manages functional contractors 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 101-250 employees