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 Clinical Trial Administrator to join our team.
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.
The successful candidate will be an experienced, self-motivated Clinical Trial Administrator (CTA) / Sr. CTA to support the day-to-day activities of the assigned Clinical Trials.
Job Duties include:
• Assist the Clinical Trial Manager (CTM) to prepare and maintain Trial Master Files (TMF) for multiple studies, ensuring tracking of ICH-GCP and/or FDA 21CRF essential study documents. Inform the CTM/Clinical Team on any outstanding document/s
• Develops knowledge of sample collection and analysis process at the study level and may perform reconciliation and/or tracking of sample manifests
• Develop and maintain tracking spreadsheets with study level information to enable accurate and efficient supply of clinical drug product (IMP) and clinical supplies to Sites, Vendors and CROs
• Support financial oversight of clinical studies through invoice tracking and reconciliation for potential change orders
• Day-to-day contact with counterpart at outside Vendor, CRO and/or trial site; daily review and identification of potential issues or problems and communicates/escalates to CTM/Clinical Team
• Tracking of patient and recruitment status using applicable spreadsheets and web portal tools
• May assist in the review of key study documents (eg, Protocol, ICF, study plans, eCRF)
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.
• Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• Computer skills including proficiency in use of Microsoft Outlook, Word, Excel and PowerPoint
• Strong oral and written communication skills
• Basic awareness of clinical trial regulations and processes
• 1-2+ years required (CTA) and >3-5 years for Sr CTA. Study coordinator from CROs or academic institutions will be considered
• High school diploma (required); BA/BS degree in life sciences or similar field (preferred)
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 at www.xencor.com EOE
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.