We seek a Director, Preclinical Sciences, to lead the planning and execution of preclinical studies, both internally and with CROs, to support the preclinical and clinical development of Xencor’s antibody therapeutics portfolio. This individual will work on multiple project teams with research, clinical, regulatory, manufacturing and quality functions to develop project strategy and advance therapeutic programs.
Job Duties Include
- Design and manage all aspects of non-clinical studies performed internally and at CROs.
- Support advancing product pipeline in accordance with company goals. Support will include PK and toxicology, as well as, in vitro or in vivo studies.
- Track study progress, identifying/implementing actions to keep projects on track
Performs CRO site visits to monitor study conduct and foster healthy relationships with CROs.
- Collaborate and coordinate activities across multiple departments within Xencor, including Research, Manufacturing, and Quality.
- Support successful regulatory filings through drafting and reviewing study-related documents (protocols, amendments and reports) for completeness, accuracy, and consistency utilizing relevant regulatory guidance documents/regulations.
- Generate departmental SOPs and Technical Reports as necessary.
- Draft relevant sections of regulatory filings (e.g. INDs, IMPDs, NDAs, etc.)
- Masters or Doctoral degree with a minimum of 8 years biotechnology or pharmaceutical company experience, in a leadership role
- Experience conducting preclinical studies that meet Global regulations
- Experience monitoring preclinical safety and PK studies performed by CRO’s; serving as liaison
- Experience in reviewing/auditing study data and reports
- Proficient knowledge of the drug development process and contents of regulatory filings (e.g. IND’s, NDA’s)
- Thorough understanding of FDA and international (e.g. ICH, OECD) regulations and guidelines governing the conduct of preclinical studies for regulatory submissions
- Demonstrate an excellent understanding of project goals, key issues/timelines, and product priorities
- Able to create work plans consistent with corporate and project strategy
- Excellent communication skills, including effective communications to both internal and external audiences
- Work independently with minimal supervision
Xencor Inc. is an innovative biotechnology company headquartered in the Los Angeles area near Pasadena and with an office in San Diego. We recently completed a successful initial public offering (IPO). We use our pioneering XmAb® technology to develop better biotherapeutics — antibodies that target new biological mechanisms and are more potent, safer and longer lasting — to improve patient outcomes and quality of life.
In addition to generating a pipeline of novel drug candidates, our XmAb® technology is being validated through our collaborative agreements with leading biopharmaceutical companies including Amgen, 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, a passion for innovation and a willingness to take risks.
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 coworkers 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 and benefits package.