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 Senior Manager / Associate Director to provide 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:
- Establish and maintain a compliance program including inspections to assess compliance with applicable procedures and policies in Clinical Development's conduct of global clinical studies
- Maintain up-to-date working knowledge of national and international standards and guidelines related to GCP
- Promote understanding, communication and coordination of the clinical quality / compliance initiatives and compliance standards
- Develop new hire on-boarding and GCP training slide decks, conduct and document ongoing Clinical Development GCP training
- Perform inspections of Clinical Development’s ongoing activities to ensure compliance with SOPs and applicable regulations and to maintain audit readiness.
- Liaise with the Quality Assurance (QA) Department and external auditors as necessary to facilitate internal audits and to investigate and corrective and preventative actions. (CAPAs)
- Work with QA to track and ensure external Clinical vendors are audited on an appropriate schedule
- Support the resolution of QA audits and resulting CAPA actions of Investigator sites and Vendors
- Provide recommended approaches and collaborate effectively with all functions within Clinical Development (e.g. Clinical Operations, Medical Monitors, Regulatory, Medical Writing etc), and other company departments to develop and investigate corrective and preventative actions (CAPAs) based on early and timely escalation of potential non-compliances issues
- Review and manage multiple compliance activities and reports of varying complexities
- Report findings (at various levels of detail) to stakeholders and management, including recommendations based upon findings
- Provide compliance metrics to management on a routine basis
- Maintain a system for tracking SOP updates and trending SOP deviations
- Serve as a subject matter expert on GCP compliance related issues on behalf of the Clinical Development organization
- Provide consultative support to Clinical Development for internal and external regulatory and quality audits
- Track and ensure closure of all Clinical Development corrective action commitments
- Provide pre-GCP inspection preparedness activities of Xencor’s clinical trial eTMF system
- Provide guidance and support to clinical study teams in the identification and investigation of potential serious GCP compliance issues at Investigator sites, with internal process and with vendors conducting clinical trial activities
- Develop tools and reports to facilitate the completion of CAPAs, provide data to support trending/signal detection of potential compliance concerns and the development of other tools to assist the organization in minimizing risk and ensure quality is integrated into our processes
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
- Strong oral and written communication skills
- Strong knowledge of regulatory compliance and QA issues within a pharmaceutical, biotech or medical device organization
- Experience in a global environment from a regulatory/GCP compliance perspective
- Current knowledge of ICH Guidelines governing clinical trials and recent global regulatory initiatives
- Must have experience in implementation of new processes
- Minimum of 6+ years of experience in pharmaceutical, biotech or medical device development; 10+ years for Associate Director
- Minimum of 2+ years of experience with project management, preferably in clinical research, regulatory compliance and/or quality responsibilities within a clinical operations organization