Director, Clinical Project Management
Xencor Inc. is an innovative biotechnology company located in the Los Angeles area (near Pasadena) and in San Diego. We have a very deep drug development pipeline including three programs currently in clinical testing with one more expected to start clinical testing in 2017 and have an excellent opportunity for a Director, Clinical Project Management to join our team. We use our pioneering XmAb® technology to develop better biotherapeutics – antibodies that target new biological mechanisms and have the potential to be more potent, safer and longer lasting – with the goal of improving patient outcomes and quality of life. In addition to generating a pipeline of novel drug candidates, with ten in clinical testing by Xencor or our partners, our XmAb® technology has enabled multiple collaborations with leading biopharmaceutical companies including Novartis, Amgen, Morphosys, Merck, CSL, Janssen(J&J), Alexion and Boehringer Ingelheim.
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 Director, Clinical Project Management responsible for the oversight 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 the communication of clinical study team status and issues, and ensures clinical study team milestones and deliverables are met.
We seek a Director, Clinical Project Management to:
Job Duties include:
- Communicate clinical study status and issues to ensure clinical study team milestones and deliverables are met.
- Oversees the management of clinical development and other project planning, including timelines, budget, and resource management.
- Leads the clinical study teams, facilitates sub-team meetings, and organizes ad hoc working groups as needed to move clinical activities forward.
- Proactively anticipates obstacles and devises and implements solutions to achieve clinical milestones through management of relevant team members which can include vendors and consultants.
- Oversees the compilation, review and editing of clinical study team documents associated with all areas of clinical development.
- Provides guidance 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.
- Strong understanding of the cost drivers and are accountable for the development, management, reconciliation of overall clinical study budget(s) and resource allocation
- Actively contributes to Clinical Operations initiatives and programs as assigned, including identifying areas of best practice and recommends process improvements, development of SOPs, WIs and department level training
- Conducts ongoing performance management, performance reviews/appraisals and career development planning for direct reports
- 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 12+ years, of clinical trials research experience/clinical project management in a pharmaceutical / biotechnology company or CRO industry
- MS / MBA / Ph.d with 8+ years, of clinical trials research experience/clinical project management in a pharmaceutical / biotechnology company or CRO industry
- Demonstrates extensive 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 work under limited supervision, determine personal work plan, and schedule tasks and activities accordingly
- Ability to accommodate shifting priorities, demands and timelines.
- 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 company leveraging outsourced work to CROs/Vendors
- Ability to establish and maintain effective working relationships with coworkers, assigned staff, and senior management
- In-depth knowledge and skill with Microsoft Project, Microsoft Word, Microsoft Excel, and other reporting and tracking tools
- Experience with SmartSheet (preferred)
- Working knowledge of ICH GCP as relates to clinical trial management
- Demonstrated financial acumen in planning and managing clinical program budgets
- Experience at/or oversight of outside clinical research vendors (CROs, central laboratories, imaging vendors, IXRS, etc.)
- Experience in Oncology and/or Autoimmune therapeutic areas (highly preferred)
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