Executive Director, Data Management

Xencor•San Diego, CA

4d•Hybrid

About The Position

Introduction: 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 an Executive Director, Data Management, to join our team. This position can be based out of our San Diego or Pasadena, CA sites. This is a hybrid position with minimum of 2 days a week on-site. Summary: Responsible for leading the strategy, operations, and evolution of Xencor’s clinical data infrastructure, ensuring high-quality data that supports rapid, informed development decisions.

Requirements

Position requires a BS degree in related field of study and a minimum of 18 years of relevant experience, with at least 12 years of clinical data management experience in the pharmaceutical or biotechnology industry, and at least 6 years of people and team management experience. Prior clinical trial responsibility for full data management lifecycle is also required.
Good working knowledge of ICH, FDA, and GCP regulations and guidelines
Thorough knowledge of related industry standards including MedDRA, WHODrug, CDASH, SDTM, and other CDISC Foundational Standards
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.
A proven people leader with experience managing, mentoring, and developing team members to achieve strong performance and organizational goals
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.

Responsibilities

Designs and executes a scalable Clinical Data Management (CDM) strategy that supports an expanding portfolio, including programs approaching Phase 3
Provides strong leadership for the CDM function. Responsible for the recruiting, training, mentoring, performance management and growth and development of the CDM department.
Provides operational leadership for acquisition, integration, quality control, and delivery of clinical trial data
Oversees vendor and technology strategy including evaluation, selection, contracting, and performance oversight for CDM services from study start-up through database lock and final reporting.
Partners with other Development functions (e.g., Clinical Operations, Clinical Development) to resolve issues and ensure that CRF designs, data transfers, extracts, and other CDM activities support high-quality analyses and regulatory compliance.
Collaborates closely with Biostatistics and Statistical Programming to ensure clinical data structure support efficient analysis, interim decision-making, and regulatory submissions
Leads implementation of risk-based data management strategies including centralized data review, dashboarding, and issue management workflows
Serves as the functional expert accountable for CDM processes, including development and implementation of enterprise data standards and documentation
Oversees the development of standards for data management documentation (e.g., including Data Management Plans, eCRF completion guidelines, coding guidelines, Data Validation Specifications)
Other duties as assigned.