Senior Director, Clinical Data Management
Biometrics | South San Francisco, CA | Full Time
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer. Led by a world-class management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
Reporting directly to the Vice President, Biometrics, the Sr. Director, Clinical Data Management will be responsible for the organization and long-term strategic leadership of Clinical Data Management unit that supports multiple drug development programs. This position will manage the operational aspects of data management supporting global drug development activities and will lead clinical data management initiatives across multiple therapeutic portfolios, as well as manage the selection and oversight of data management vendor partners. The position requires a broad, comprehensive and detailed knowledge of Data management platform and software, clinical trial databases, and pharmaceutical drug development process. The successful candidate will provide leadership and guidance to the Clinical Data Management department and will be responsible for supporting end-to-end data management activities, including the development and implementation of data standards based on CDASH/SDTM.
Responsibilities include, but are not limited to:
- Establish and provide leadership to the Global Data Management team at Allogene to set a high performance and collaborative culture
- Ensure quality processes for data management through SOPs, training, and internal and external inspection activities Establish best in class processes and standards for the generation and reporting of data
- Provide data management representation and leadership on internal cross-functional teams, in addition to regulatory agencies
- Work collaboratively with internal and external team members to coordinate the planning and execution of day to day data management deliverables
- Provide expertise and guidance to the clinical development team regarding CDASH and CDISC data standards
- Build and lead a team of high performing clinical data managers to meet business objectives
- Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives
- Oversee database status with respect to key performance indicators, metrics, and program level deliverables and timelines
- Contribute to project resource planning, re-forecasting, and program milestones
- Other duties as assigned
Position Requirements & Experience:
- Masters degree (or higher) in Statistics, Computer Science or other closely related field to programming with at least 14 years of clinical/statistical programming experience within pharmaceutical industry and at least 5 years of demonstrated leadership experience and career progression
- Experience in development and implementation of Clinical data management standards and procedures is required
- Thorough command of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
- Experience in regulatory GCP inspections/audits
- Demonstrated ability to manage staff that leads projects for clinical data management and mentoring junior data managers and leading teams supporting NDA and IND filings
- Adept at outsourcing and managing services provided by clinical data management vendors and contractors
- Extensive experience interacting with regulatory agencies, both US and ex-US
- Flexible to changing priorities, detail-oriented, works well under pressure with initiative to take on unfamiliar tasks
- Demonstrated ability to establish and articulate a plan for a team to ensure appropriate focus and direction and to accept responsibility for individual and team performance (accountability & ownership)
- Demonstrated ability to evaluate business impact of decisions, follow through on agreed upon decisions, and remain flexible when needed
- Strong analytical skills and demonstrated experience in gathering, interpreting and analyzing data in clinical research and drug development
- Excellent organizational skills and an ability to prioritize effectively to deliver results within aggressive timelines
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Candidates must be authorized to work in the U.S.
As an equal opportunity employer, Allogene Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact the careers email at www.allogene.com for assistance.
For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster