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/an [insert title] 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.
Responsible for the maintenance of the electronic Trial Master Files (TMF). Performs ongoing reviews of TMF to assure quality of the documentation files and compliance with Xencor SOPs, GCP and ICH Guidelines
Responsible to develop and review regulatory documentation to support study start up activities, including ensuring all site supplies are available on site for site initiation visits
Acts as primary liaison for assigned study sites, CROs and Vendors to convey project information, answer questions and resolve issues in accordance with the CTM escalation pathway
Attends Investigator Meetings and study-specific training for assigned trials
Ensures all regulatory documents and study supplies are maintained during the lifecycle of assigned clinical trials in collaboration with the CTM
Monitors subject recruitment and treatment status remotely through IxRS and EDC systems and direct communication with sites in order to update detailed tracking sheets daily
Preparation and review of various study related tracking sheets to determine and report status of clinical trial documents (distribution, status, retrieval of such documents as protocol, IB, etc.) and responsible for the follow up to collect outstanding documents
Understanding of assigned clinical trial protocol(s) and trial specific manuals/plans to ensure quality and deliverables are met across assigned trials
Participate in the study budget process and invoice tracking for 3rd party CROs, Vendors, Consultants and Clinical Sites
In partnership with the CTM, may prepare meeting agenda, minutes and action items
Taking the initiative and identifying new approaches to resolve problems and mitigate risks
Serves as mentor for junior CTAs and those new to the company and/or trial
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.
Excellent 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
Understanding of clinical trials, drug development, Phase I through Phase III
Computer skills including proficiency in use of Microsoft Outlook, Word, Excel and PowerPoint
Experience with SmartSheet (desired)
Experience with Veeva Vault eTMF system (strongly preferred)
Solid working knowledge of ICH GCP as relates to clinical trial management
BS/BA degree in Life Science (strongly preferred)
Typically requires a minimum of 2-4 years of direct expertise with clinical site management, CRO/Vendor management and logistical execution of clinical trials required
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 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.