Clinical Project Manager
San Diego, California
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 Project Manager to join our team.
Our protein engineering 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 broad portfolio enabled by the rapid expansion of our bispecific technologies, and nine XmAb bispecific antibodies and cytokines 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 worldwide.
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 clinical operations professional, and self—motivated Clinical Project Manager responsible for the support of clinical development timeline deliverables with a clear understanding of functional interdependencies and critical path activities. Accountable for supporting various clinical development functional areas on projects in a timely and cost—effective way. Manages vendors, consultants, and budgets through contractual agreements of various projects. Responsible for supporting the Director, Clinical Project Management and Head of Clinical Operations and communication of clinical study team status and issues to ensure clinical study team milestones and deliverables are met.
We seek a Clinical Project Manager to:
Job Duties include:
• Support the Director, Clinical Project Management and Head of Clinical Operations
• Communicate clinical study status and issues to ensure clinical study team milestones and deliverables are met
• Supports the clinical study teams in project planning, including timelines, budget, and resource management, development of team agenda and minutes with action items
• Supports the clinical study teams, facilitates sub-team meetings, and organizes ad hoc working groups as needed to move clinical activities forward
• Provides support to team members to objectively assess and resolve project management issues by identifying root causes as opportunities to improve project
effectiveness; coaches team members to be proactive in resolving issues
• Understanding of the cost drivers and are accountable for the development, management, reconciliation of overall clinical study budget(s)
• Actively contributes to Clinical Operations initiatives and programs as assigned, including identifying areas of best practice and recommends process improvements,
development of SOPs, Wls, department level training and clinical study metrics
• Responsible for building esprit de corps within the clinical department
• 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.
• BA/BS or equivalent degree in scientific discipline with 5+ years, of clinical trials research experience/clinical project management in a pharmaceutical /
biotechnology company or CRO industry
• Demonstrates technical expertise in and understanding of cross-function clinical trials processes from study start-up through study closure (e.g., data management,
safety, biostatistics, medical writing)
• Excellent attention to detail and accuracy in work with proven ability to work independently, with a high level of integrity on multiple tasks Strong work ethic, willing to put in the time and effort to complete critical tasks on time with quality
• Excellent sense of urgency to deliver at/surpass study conduct targets
• Ability to support multiple project teams simultaneously, be well organized and have strong time management skills and attention to detail.
• Ability to accommodate shifting priorities, demands and timelines.
• Ability to work under limited supervision, determine personal work plan, schedule tasks and activities accordingly.
• Ability to elicit cooperation from a wide variety of sources and to be persuasive, encouraging and motivating
• Proven experience working in an emerging biotechnology/pharmaceutical/CRO
• Ability to establish and maintain effective working relationships with coworkers, assigned staff, and senior management
• Basic knowledge and skill with Microsoft Word, Microsoft Excel, and other and tracking tools
• Experience with SmartSheet (preferred)
• Working knowledge of ICH GCP as relates to clinical trial management
• Basic understanding of financial planning and managing clinical program budgets.
• Experience at/or oversight of clinical research vendors ( CROs, central imaging vendors, IXRS, et)
• Experience in Oncology and/or Autoimmune therapeutic areas (highly preferred)
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.
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