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Xencor

Clinical Project Manager

Clinical Operations – San Diego, California
Department Clinical Operations
Employment Type Full Time
Minimum Experience Manager/Supervisor

                                                                  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 capabilities and the modular nature of our 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 technologies. Five XmAb® bispecific antibody programs are in clinical testing, and two more are expected to start clinical testing in the first half of 2019. 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 12 XmAb® drug candidates 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.

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.

 

Qualifications/Requirements:

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)

 

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

 

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  • Location
    San Diego, California
  • Department
    Clinical Operations
  • Employment Type
    Full Time
  • Minimum Experience
    Manager/Supervisor
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