Clinical Compliance Associate
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 a Clinical Compliance Associate 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.
The successful candidate will be an experienced, self-motivated Clinical Compliance Associate to provide support to the strategy and management of clinical compliance and quality related projects and activities in the Clinical Development organization. Responsible for compliance with applicable Corporate and Divisional Policies and SOPs.
Job Duties include:
- Support the ongoing development and maintenance of the Xencor Clinical Development Quality Management System (QMS)
- Assist with compliance checks across clinical trial activities to ensure adherence to quality management processes, standard operating procedures, and trial specific plans
- Contribute to the delivery of Xencor Clinical Compliance objectives by supporting multiple compliance activities of varying complexities
- Maintain current working knowledge of Good Clinical Practice (GCP)
- Support the development of processes and tools compliant with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) – Good Clinical Practice (GCP) principles
- Perform ongoing review, tracking, and reporting of data and documentation to monitor quality and compliance activities and support trending/signal detection of potential compliance concerns
- Collaborate effectively with all functions within Clinical Development, Quality Assurance (QA) and other applicable departments within Xencor to support Clinical Compliance activities
- Support Xencor clinical trial teams to remain inspection ready and compliant with internal processes, study protocols, ICH-GCP and applicable regulations
- Promote understanding, communication, and coordination of the Xencor clinical quality / compliance initiatives and compliance standards
- Track and verify status of ongoing Clinical Development Corrective Action Preventative Action (CAPA) plans
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.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
- Excellent organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
- Ability to work independently with minimal supervision
- Computer skills including proficiency in use of Microsoft Outlook, Word, Excel and PowerPoint (advanced Excel knowledge preferred)
- Strong oral and written communication skills
- Working knowledge of regulatory compliance and QA issues within a pharmaceutical or biotechnology company
- Current knowledge of ICH Guidelines governing clinical trials and recent global regulatory initiatives
- Minimum of 2 years of experience in pharmaceutical or biotech development
- Experience in clinical research, regulatory compliance and/or quality responsibilities within a clinical operations organization
- In-house role with minimal Travel required (avg. 10% or less)
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.
Americans with Disabilities Act (ADA) Statement
The Company will provide reasonable accommodations (such as a qualified sign language interpreter or other personal assistance) with the application process upon your request as required to comply with applicable laws. If you have a disability and require assistance in this application process, please contact HR@xencor.com.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
Equal Employment Opportunity (EEO) Statement
The Company is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender or gender identity, national origin, disability status, protected veteran status or any other characteristic protected by state or federal law.
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.