Clinical Scientist/Senior Clinical Scientist- San Diego
Xencor Inc. is an innovative biotechnology company located in the Los Angeles area (near Pasadena) and in San Diego. We have a very deep drug development pipeline including three programs currently in clinical testing with two more expected to start clinical testing in 2017 and have an excellent opportunity for a Clinical Scientist/Senior Clinical Scientist to join our team. We use our pioneering XmAb® technology to develop better biotherapeutics – antibodies that target new biological mechanisms and have the potential to be more potent, safer and longer lasting – with the goal of improving 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 enabled multiple collaborations with leading biopharmaceutical companies including Novartis, 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 and flexibility and demand from each other scientific rigor, a passion for innovation, and a willingness to take risks.
The Clinical Scientist/Senior Clinical Scientist will play an integral role in facilitating successful and timely initiation and completion of the Company’s clinical development programs. The Clinical Scientist/Senior Clinical Scientist will work directly with members of the Clinical Development group and with Xencor Clinical Operations, Clinical Project Managers, Data Management and Biostatistics, Clinical Research Organizations (CROs) and Clinical Investigators to plan, execute and monitor medical aspects of selected 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 process. The Clinical Scientist/Senior Clinical Scientist will have a strong familiarity with good clinical practices, be a highly motivated, hands on, detail oriented individual with the ability to formulate, develop and execute clinical trials and be able to operate in a highly dynamic environment.
We seek a/an Clinical Scientist/Senior Clinical Scientist to
Job Duties include :
•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
•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 (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
•Participates as a standing member of multidiscipline Project Teams
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.
•Degree in life sciences (RN, PharmD, MD) with clinical research experience and strong hands-on working knowledge of drug development. MD preferred (Board certified in Internal Medicine is a plus)
•5+ years’ directly relevant experience in clinical research management with previous experience as a clinical scientist or medical director, including: trial medical monitoring, hands on experience with clinical operations, and experience liaising with clinical trial teams and 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
•Experience in analysis and interpretation of emerging clinical data, including use of software packages to analyze data (e.g. pivot tables): MS Office Suite, Visio, Graphpad, Spotfire etc
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