Executive Director, Data Management

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 . We have an excellent opportunity for an Executive Director Data Management to join our 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 Xencors clinical data infrastructure ensuring high-quality data that supports rapid informed development decisions. Primary Responsibilities:Designs and executes a scalable Clinical Data Management (CDM) strategy that supports an expanding portfolio including programs approaching Phase 3Provides strong leadership for the CDM function. Responsible for the recruiting training mentoring performance management and growth and development of the CDM operational leadership for acquisition integration quality control and delivery of clinical trial dataOversees 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 submissionsLeads implementation of risk-based data management strategies including centralized data review dashboarding and issue management workflowsServes 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 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 also requires:Good working knowledge of ICH FDA and GCP regulations and guidelinesThorough knowledge of related industry standards including MedDRA WHODrug CDASH SDTM and other CDISC Foundational StandardsUnderstanding of data management technology software languages and computer systemsSound knowledge of clinical trial process and data management clinical operations biometrics quality management and systems applications to support operationsCompetency 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 emailExcellent verbal/written and interpersonal skillsAbility to create strong collaborative working relationships and encourage creative solutions by effectively working through to demonstrate competencies applicable for job based on Xencors Leadership Competency ModelAbility to effectively manage others through coaching and supervision in accordance with company policies and practices. Ensures employee performance meets the organizations expectations for conduct productivity quality continuous improvement and goal travel may be required including travel between Xencors Pasadena and San Diego offices. Work for this position is generally performed at Xencors worksite and requires full-time commitment. Expected Base Salary Range: $263000 - $315000The actual salary will be based on the selected candidates qualifications including skills competencies education and offers a competitive total rewards package including 401k match healthcare coverage ESPP and a broad range of other addition this position will be eligible for an annual bonus and equity grant. For more information please see with Disabilities Act (ADA) StatementThe Company will provide reasonable accommodations (such as a qualified sign language interpreter or other personal assistance) with the application process upon your request as required to comply with applicable laws. If you have a disability and require assistance in this application process please contact perform this job successfully an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential Employment Opportunity (EEO) StatementThe Company is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to age race color religion sex sexual orientation gender or gender identity national origin disability status protected veteran status or any other characteristic protected by state or federal 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.