Xencor is an innovative, clinical-stage biopharmaceutical 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 an Associate Director, Clinical Trial Management to join our team.
Our capabilities and the modular nature of XmAb technology allows 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 antibody and cytokine technologies. Nine XmAb bispecific antibody programs are in clinical testing, and more are expected to start clinical testing in 2021. We also leverage our many XmAb technologies by engaging in multiple collaborations with leading global biopharmaceutical companies, including Novartis, Amgen and Genentech, among others. We and our partners are advancing 18 XmAb drug candidates through clinical development, and two medicines that incorporate XmAb technology are approved for commercial marketing.
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.
Job Duties include:
- In concert with Study Medical Monitors, create required clinical trial documents including clinical protocols, investigator brochures, DSURs and clinical modules of the IND
- Work closely with Clinical Operations to execute the clinical trial with high quality and according to timelines
- Perform ongoing review of clinical data, query generation/resolution and data analysis, including review of draft listings to support data cleaning and interpretation
- Provide scientific expertise to Clinical Operations by responding to questions or clarifying issues arising during study conduct
- Provide internal safety monitoring for clinical trials in collaboration with the Study Medical Monitors
- Provide medical input for the clinical database build, CRFs, monitoring plan, data management plan, safety monitoring plan and statistical analysis plan
- Develop and maintain relationships with clinical trial investigators and therapeutic area key opinion leaders as needed
- Lead review of study data (e.g. Tables, Listings and Figures and emerging bioanalytical data) and development of CSRs, clinical presentations and publications
- Support other members of Clinical Development and Regulatory Affairs departments, as may be required
- Participate as a standing member of multidiscipline Project Teams
- Degree in life sciences (PhD, RN, PharmD, MS, BS) with oncology clinical research experience and strong hands-on working knowledge of drug development
- 5+ years’ (4+ years in oncology) directly relevant pharmaceutical industry experience in clinical development with previous experience as a clinical scientist, including: data review, safety monitoring, protocol development, supporting data analyses, interpretation and publications, experience working on cross functional clinical trial teams and liaising with study investigators
- Prior experience with relevant tasks throughout the entire study life cycle, from study concept to database lock and CSR, is a plus.
- Prior experience with monoclonal antibody biologics/immunotherapy 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 (e.g. able to adjust style/contents to suit the audience/purpose)
- Experience in analysis and interpretation of emerging clinical data, including use of software packages to analyze data (e.g. pivot tables) and EDC: MS Office Suite, Visio, GraphPad Prism, Spotfire, Medidata RAVE, Inform etc. Physical Demands:
- The physical demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.
- The physical demands of the office are normally association with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply. Work is performed in an office environment.
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. For further information about Xencor, please visit our website atwww.xencor.com EOE