Senior Manager, 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 management team with significant experience in cell therapy, Allogene is developing a pipeline of “offthe-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.
Position: Senior Manager, Clinical Data Management
Location: South San Francisco, CA
Reporting directly to the Head of the Clinical Data Management, the Senior Manager, Clinical Data Management will be responsible for the strategic leadership of the Clinical Data Management unit supporting a specific drug development program. This individual will manage the operational aspects of data management supporting global drug development activities of a program, including the selection and oversight of data management contractors / vendor partners. The position requires a detailed knowledge of Data management platform and software, clinical trial databases, and Pharmaceutical drug development process. The successful candidate will provide direction and guidance to the Clinical development team and will be responsible for supporting end-to-end data management activities for one or more studies.
Responsibilities include, but are not limited to:
- Establish and provide leadership to the Global Data Management team for a product development project at Allogene to set a high performance and collaborative culture
- Provide data management representation and guidance on internal cross-functional clinical teams
- 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 data standards
- Lead a team of high performing clinical data management consultants / vendors to meet business goals
- Effectively interact with senior members in Biometrics for strategic planning to ensure internal standards 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 deliverable timeline
- Other duties as assigned
Position Requirements & Experience:
- Bachelor’s degree (or higher) in Statistics, Computer Science or other closely related field to programming with at least 6 years of clinical/statistical programming experience within pharmaceutical industry and at least 3 years of relevant clinical trial experience.
- Experience implementing Clinical Data Management standards and procedures is required
- Experience in regulatory GCP inspections/audits is a plus
- Demonstrated ability to manage staff that delivers project goals for clinical data management and mentoring junior data managers
- Successfully manage clinical data management vendors, contractors and service providers
- Flexible to changing priorities, and detail-oriented, with initiative to take on unfamiliar tasks
- Demonstrated ability to establish and articulate a plan for a team to ensure appropriate focus and direction
- Good analytical skills and demonstrated experience in gathering, interpreting and analyzing data in clinical research and drug development
- 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.