Xencor Inc. is an innovative biotechnology company located in the Los Angeles area (near Pasadena) and in San Diego. We have a very deep drug development pipeline including two programs currently in clinical testing with two more expected to start clinical testing in 2016 and have an excellent opportunity for a Lead/Senior Scientist, Pharmacokinetics to join our team. We use our pioneering XmAb® technology to develop better biotherapeutics – antibodies that target new biological mechanisms and have the potential to be more potent, safer and longer lasting –with the goal of improving patient outcomes and quality of life. In addition to generating a pipeline of novel drug candidates, with nine in clinical testing by Xencor or our partners, our XmAb® technology has enabled multiple collaborations with leading biopharmaceutical companies including Novartis, Amgen, Novo Nordisk, Morphosys, Merck, CSL, Janssen(J&J), Alexion and Boehringer Ingelheim.
Our employees are the most important factor in our success and we have assembled a highly talented group from diverse backgrounds and disciplines to execute our business plan and shape our future. Xencor employees value new ideas and flexibility and demand from each other scientific rigor, a passion for innovation, and a willingness to take risks.
The Preclinical Sciences Department is seeking a PhD level scientist to lead the investigation of pharmacokinetic and pharmacodynamic (PK/PD) relationships for novel antibody therapeutics in preclinical models and for bridging preclinical PK/PD information to clinical research. This position is located at Xencor’s headquarters in Monrovia, CA and will report to the Director, Preclinical Sciences & Quality Control.
Job Duties Include:
• Responsible for performing analyses of preclinical PK/PD data; provide support for clinical PK/PD data analyses as needed
• Manage PK Scientist contractors to support additional workload, as needed.
• In collaboration with technical experts, manage contract laboratories to deliver pharmacokinetic, immunogenicity, and biomarker data and reports according to study timelines
• Develop PK/PD models to support dosing strategies for clinical programs
• Author technical study reports and regulatory submissions
• Provide data analysis support to Preclinical Sciences, Bioanalytical Development, Quality Control, and Research, as needed
• Maintain current knowledge of the field and area(s) of scientific expertise and development
• Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Biomedical Engineering or related discipline
• 5 or more years of biotech or pharmaceutical industry experience in evaluating the pharmacokinetic properties of antibody therapeutics is required
• Strong knowledge and experience in immunology and/or oncology, preferred
• Must be proficient with hands-on PK NCA analysis and data reporting using Phoenix WinNonLin
• Proficiency in population PK/PD analysis is desired
• High competence in additional common software and data analysis packages (eg, Microsoft Office Suite, SoftMax Pro, GraphPad Prism, JMP or MiniTab, NONMEM, NLME)
• Experience managing external service providers and CRO’s with timely delivery of clear and accurate well written study findings.
• Strong knowledge of drug development and FDA and ICH guidance documents is essential
• Excellent communication skills, including technical writing and verbal communications for productive cross-functional team interactions
We strive to create an environment that will challenge, motivate, and reward our employees for meeting the changing demands of creating breakthrough therapeutics. Xencor has a highly collaborative structure that integrates co-workers with different skill sets into teams for product and technology development. With an emphasis on attaining the best and most highly qualified candidates in their respective fields, we offer a competitive salary & benefits package.