Xencor Inc. is an innovative biotechnology company located in the Los Angeles area (near Pasadena) and in San Diego. We recently completed a successful IPO and have an excellent opportunity for a Director/Senior Director Clinical Development to join our team in San Diego. 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, with ten in clinical testing by Xencor or our partners, our XmAb technology has been validated through our collaborative agreements with leading biopharmaceutical companies including 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.
We seek a Director Clinical Development to manage the planning, execution and interpretation of clinical trial research.
The Director Clinical Development will play an integral role in helping lead the Companys clinical development programs and serve as the Medical Director for selected company clinical studies. The Director/Sr. Director Clinical Development will work directly with Clinical Project Managers, Clinical Research Organizations and Clinical Investigators to ensure successful execution of clinical trials. The successful candidate will operate in a highly detailed and organized fashion, with the goal of efficiently driving each program through the clinical development and approval process for the Companys therapeutic candidates. The Director/Sr. Director Clinical Development will have a strong familiarity with good clinical practices, be a strategic thinker with ability to formulate, develop and execute clinical trials and be able to operate in a highly dynamic environment.
- Design clinical trial strategy and create required clinical trial documents including clinical protocols, investigator brochures, ICFs and clinical modules of the IND
- Work closely with Clinical Operations to execute the clinical trial with high quality and according to timelines
- Provide safety monitoring for clinical trials and create safety monitoring plan.
- Provide medical input for the clinical database build, CRFs, monitoring plan, data management plan, and statistical analysis plan
- Develop and maintain relationships with clinical trial investigators and therapeutic area key opinion leaders
- Lead review of study data and development of CSRs, clinical presentations and publications
- Support other members of Clinical Research and Development and Regulatory Affairs departments as may be required
- Participates as a standing member of multidiscipline Project Teams
Requirements, Knowledge, Skills and Abilities:
- MD required. Board certified in Internal Medicine is a plus; however, the Company is open to other specialties and/or experience.
- 5 years directly relevant experience in clinical research management with previous experience as a medical director, including: trial medical monitoring, hands on experience with clinical operations, and experience liaising with study investigators
- Prior experience with monoclonal antibody biologics clinical development is a plus.
- Experience in translational medicine/early phase clinical trials is a plus
- Self-starter, highly motived, highly organized and hands on with outstanding attention-to-detail
- Able to work independently and prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment
- Excellent written and oral communication skills and interpersonal skills
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. Please submit a cover letter & resume to *********************. For further information about Xencor, please visit our website at ************** EOE
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Website : http://www.xencor.com