Director, Clinical Data Management

Xencor•San Diego, CA

22h•$195,000 - $240,000•Hybrid

About The Position

Xencor is a public, clinical-stage biopharmaceutical company located in the Los Angeles area (Pasadena) and in San Diego. Our focus is developing high-potential XmAb® bispecific T-cell engagers and additional engineered drug candidates that leverage our differentiated technology platforms, and we are advancing our pipeline toward clinical proof-of-concept decisions. Our goal is to create high-impact therapeutics for patients with cancer and other serious diseases. More than 20 XmAb drug candidates engineered with our technology are in clinical development, and three XmAb medicines have been marketed by partners. For more information, please visit www.xencor.com. We have an excellent opportunity for a Director, Clinical Data Management, to join our team. This position will be based out of our San Diego, CA. office and is a minimum 2 days a week onsite hybrid position. Summary: Responsible for oversight of all Data Management operational activities ensuring compliance with the corporate timeline and scope of work outsourced to CDM Contract Research Organizations.

Requirements

Position requires a BS in a Life Sciences, Computer Sciences or Mathematics field of study and a minimum of 12 years of related experience, with at least 5 years of data management experience in the pharmaceutical or biotechnology industry, and at least 5 years of people management experience. Prior clinical trial responsibility for the entire data management life cycle is also required.
Good working knowledge of ICH, FDA, and GCP regulations and guidelines
Strong well-rounded technical skills including CDISC, STDM, MeDRA
Understanding of data management technology, software languages and computer systems
Sound knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations
Competency in multiple computer-based tools, in addition to software programs such as Word, PowerPoint, Excel, etc.
Ability to work in and effectively contribute to cross-functional teams in face-to-face conversation, by telephone, and by email
Excellent verbal/written and interpersonal skills
Ability to create strong, collaborative working relationships and encourage creative solutions by effectively working through conflicts.
Ability to demonstrate competencies applicable for job based on Xencor’s Leadership Competency Model
Ability to effectively manage others through coaching and supervision, in accordance with company policies and practices.
Ensures employee performance meets the organization’s expectations for conduct, productivity, quality, continuous improvement, and goal accomplishment.
Occasional travel may be required, including travel between Xencor’s Pasadena and San Diego offices. Work for this position is generally performed at Xencor’s worksite and requires full-time commitment.

Responsibilities

Provides operational leadership to the direction, design, planning, execution, collection and handling of all clinical data to the highest quality standards
Oversees vendor and technology evaluation, qualification and selection, budget assessment and contract negotiations, training and oversight for all CDM services from study start-up through study close-out and final reporting
Responsible for building effective Data Management vendor relationships for all assigned studies, including involvement in RFP development, contract negotiation and selection of DM and/or technology
Creates and/or reviews study specific Data Management and database documentation which may include data management plans, CRF completion guidelines, coding guidelines, annotated CRFs, and edit check specifications
Ensures clinical databases and external data files are designed in a standard, accurate, complete and consistent format to produce datasets that are conducive to analysis and regulatory submission by working with lead CRO data manager or equivalent
Coordinates and participates in the review of clinical data, analysis tables/listings/figures and patient profiles for data consistency and accuracy
Ensures clinical data within the clinical DB is of a quality to lock as appropriate for clinical review and statistical analysis
Ensures that all clinical trials have complete and accurate data and supporting documentation for regulatory submission and data analysis including raw datasets and bookmarking annotated CRFs
Maintains study-specific files to enable the reconstruction and evaluation of data management conduct in a clinical trial
Manages DM-related timelines; coordinates and synchronizes deliverables and milestones with overall timelines
Implements documentation and archival standards of Data Management deliverables including DM systems, databases, programs, and specifications
Provides training of the CRF completion guidelines, EDC system at Investigators' meeting and to internal and external project members as needed
Adheres to all department and company-wide policies regarding conduct, performance and procedures
Provides oversight and direction to direct and indirect reports, as applicable, in accordance with the organization’s policies and procedures. The responsibilities may include, but are not limited to recruiting, training, communicating job expectations, appraising and managing job performance, delivering feedback and coaching, and providing career development planning and opportunities.
Performs other duties as required.