Associate Director/Director, Toxicology

PreClinical Sciences · San Diego, California
Department PreClinical Sciences
Employment Type Full Time
Minimum Experience Experienced

Associate Director/Director, Toxicology

Monrovia or San Diego

 

Xencor is an innovative, clinical-stage biotechnology company located in the Los Angeles area (near Pasadena) and in San Diego. We use our pioneering XmAb® technology to discover and develop better biotherapeutics – antibodies and other proteins with improved function – with the goal of improving patient outcomes and quality of life, and we have an excellent opportunity for a/an [insert title] to join our team. 

 

Our protein engineering capabilities and the modular nature of our technology allow us to quickly identify and create new platforms and drug candidates for potential development. We are developing a broad portfolio enabled by the rapid expansion of our bispecific technologies, and nine XmAb bispecific antibodies and cytokines are in clinical testing. We also leverage our many XmAb technologies by engaging in multiple collaborations with leading global biopharmaceutical companies, including Novartis, Amgen and Genentech, among others. Including our partners, over a dozen XmAb drug candidates are advancing through clinical development, and the first antibody that incorporates an XmAb technology has been approved for commercial marketing worldwide.

 

We seek a Toxicologist to lead the nonclinical safety evaluation and strategic development of engineered antibody therapeutic products. The role includes the design, execution, analysis, and reporting of mostly non-human primate studies (non-GLP and GLP) performed exclusively at contract laboratories. In addition, the successful candidate will represent Preclinical Sciences on research program and clinical development teams and lead the teams through assembly of scientifically-sound, nonclinical regulatory packages and query responses. The role is not responsible for the conduct of research pharmacology or animal models of disease studies, though understanding them in consideration of toxicology study results is important.

 

Responsibilities include but are not limited to*:

  • Successfully interacts with other functional area experts in a project team environment to recommend the best course of nonclinical development for a given program and defend those recommendations to executive management
  • Design appropriate toxicology and PK/PD studies to support large-molecule drug development
  • Provide scientific leadership, monitoring, and approval of studies implemented at contract laboratories
  • Analyze and interpret results and make recommendations to teams and senior management
  • Prepare study reports and appropriate sections of the common technical documents for regulatory submissions and queries on development candidates. Potentially interact with health authorities
  • Prepare and/or review safety risk assessments for product quality and safety
  • Maintain current knowledge of the field and area(s) of scientific expertise and development

 

Qualifications:

  • PhD and/or DVM in Toxicology, Pharmacology, Oncology, Immunology or a related science
  • 8+ years of industry experience in conducting toxicology studies, including the assessment of antibody-based therapies
  • Certification by the American Board of Toxicology (DABT) is highly preferred
  • Experience as a GLP Study Director and/or Sponsor Monitor for non-human primate studies
  • Proven track record of collaboration on project teams matrixed across functions, including contract laboratories and corporate partners
  • Strong in vivo study background with an understanding of mechanisms of immunomodulation for the treatment of cancer and inflammatory diseases
  • Must be able to demonstrate sound theoretical and experimental background in biology coupled with technical proficiency, scientific creativity, collaboration with others and independent thought
  • Exceptional verbal and written communication skills; ability to communicate clearly and effectively with scientific colleagues and executive management
  • Excellent organizational documentation, negotiation and interpersonal skills; adaptive learning and critical thinking
  • Thrives in an entrepreneurial environment with initiative and flexibility in delivering independent and matrixed team contributions
  • High functionality in MS Office (Word, Excel, Outlook, PowerPoint) and data analysis and graphing software (e.g., WinNonlin, GraphPad Prism, Spotfire, JMP)

 

*Please note this job description is not written to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

 

**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.

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  • Location
    San Diego, California
  • Department
    PreClinical Sciences
  • Employment Type
    Full Time
  • Minimum Experience
    Experienced