Associate Director/Director Preclinical Development

Preclinical Development · Monrovia, California
Department Preclinical Development
Employment Type Full Time

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 Associate Director/Director, Preclinical Development.

Our 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 deep pipeline of novel drug candidates enabled by the rapid expansion of our bispecific technologies, and seven XmAb bispecific antibody programs 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 in the United States.

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.

We seek an Associate Director/Director to lead the preclinical safety pharmacology/toxicology 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. Leads the research preclinical project team through assembly of scientifically sound preclinical regulatory packages and query responses. Preclinical representative to clinical development project teams. The role is not responsible for the performance of research pharmacology or animal models of disease.

Some responsibilities include:

  • Successfully interacts with other functional area experts in a project team environment to recommend the best course of preclinical development for a given program and defend those recommendations to executive management
  • Design appropriate PK/PD and toxicology 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 submission and queries on development candidates. Potentially interacts with health authorities
  • Prepare safety risk assessments for product quality and safety
  • Maintain current knowledge of the field and area(s) of scientific expertise and development

Qualifications:

  • DVM or PhD in Pharmacology, Toxicology, Oncology, Immunology or related science 
  • 5+ years industry experience in conducting toxicological research, including assessment of antibody-based therapies
  • Certification in Toxicology (DABT) is highly preferred
  • Experience as a GLP Study Director and/or Sponsor Monitor for non-human primate studies
  • Strong in vivo pharmacology background with an understanding of mechanisms of immunomodulation for the treatment of cancer and inflammatory diseases
  • Proven track record in the management of project teams matrixed across functions and companies, including contract laboratories and corporate collaborations
  • High functionality in MS Office (Word, Excel, Outlook, PowerPoint) and data analysis and graphing software (eg., WinNonLin, GraphPad Prism, SpotFire, JMP)
  • Exceptional verbal and written communication skills; ability to communicate clearly and effectively with scientific colleagues and executive management
  • Must be able to demonstrate sound theoretical and experimental background in biology coupled with technical proficiency, scientific creativity, collaboration with others and independent thought
  • 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
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

*Please note this job description is not designed 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
    Monrovia, California
  • Department
    Preclinical Development
  • Employment Type
    Full Time