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Xencor

Senior Manager, Clinical Data Management

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

 

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 Senior Manager, Clinical Data Management to join our team.

Our 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 deep pipeline of novel drug candidates enabled by the rapid expansion of our bispecific technologies, and seven XmAb bispecific antibody programs 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 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.

We seek a Sr. Mgr. CDM to Oversee CRO Full Service Vendor performance, and partner with cross functional study teams to ensure delivery of the Xencor portfolio.  This individual achieves results through effective communication, teamwork, performance management, collaboration with other groups and a commitment to serving internal and external customers and stakeholders.

This individual will ensure the highest quality data, as well as consistency across the Data Management Organization and Clinical Development Program.

This individual will report to the Associate Director of Clinical Data Management.

Core Responsibilities include:

• Partnering with CDM vendors and cross functional study teams to ensure advancement of the Projects, Programs and Company portfolio.

• Management of vendor deliverables and relationships while representing Xencor as the point of contact for all assigned CDM activities and functions.

• Ensuring that data management activities are conducted in accordance with GCP, GCMP, internal SOPs and all regulatory requirements

• Leading and/or participating in the development, review and implementation of processes, policies, SOPs and associated documents affecting CDM internal and cross-functional working groups

• Reviewing CDM documents within a project area to ensure consistency and quality

• Overview of project timelines and metrics to ensure DM deliverables are met

• Approval of database locks, snapshots, and all relevant CDM deliverables

• Contributing to the continuous improvement of DM and the wider Development organization through information sharing, training and education

• Development and coordination of study and project level training for relevant staff

• Contributing to the continuous improvement of DM and the wider Development organization through information sharing, training and education

• Communication and escalation of study and program level issues including processes, timelines, resourcing, performance, etc. 

• Maintaining documentation and archival standards for Data Management deliverables including systems, databases, programs, and specifications

• Maintaining study-specific files to enable the reconstruction and evaluation of data management conduct in a clinical trial

Requirements:

• Strong knowledge of drug development processes

• Proven success in management of CDM, projects, vendors, CRO’s

• Excellent management, collaboration, communication and decision making skills

• Knowledge of FDA/ICH guidelines and industry standard practices regarding data management and GCDMP

• Ability to multi-task in a dynamic environment

• Committed to integrity, accountability, transparency, scientific rigor and drive

Qualifications: 

• Bachelor’s degree in computer science, mathematics, life sciences or relevant field.

• Pharmaceutical, Biotechnology or relevant clinical CRO experience, including 6+ years in clinical data management

• CDM Project Management is preferred (oversight of CRO’s, electronic data vendor management, timeline management, etc.…)

• Previous experience with CDM systems including EDC (Medidata RAVE) and a sound understanding of CDM processes, database structure and programming concepts, and Clinical Development

• Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, etc.)

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 to recruiting@xencor.com.  For further information about Xencor, please visit our website at www.xencor.com  

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