Internal Application: Director, Clinical Data Management
Biometrics | Remote in South San Francisco, CA | Full Time | From $200,000.00 to $240,000.00 per year
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™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product 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 X (formerly Twitter) and LinkedIn.
About the role:
The Director, Clinical Data Management will be responsible for the leadership of the Clinical Data Management, within the Biometrics organization. This individual will manage the strategic and operational aspects of data management supporting global drug development activities across Allogene programs, including the selection and oversight of data management contractors / vendor partners and management of external laboratory data. 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 Allogene’s drug development programs and 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 and Clinical Operations 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
- Provide hands-on support for individual programs and studies as needed
Position Requirements & Experience:
- Bachelor’s degree (or higher) and experience within pharmaceutical industry and 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 and creative with 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.
We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package, which includes an annual performance bonus, equity, health insurance, generous time off (including 2 annual holiday company-wide shutdowns) and much more. The expected salary range for this role is $200,000 to $240,000. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.
As an equal opportunity employer, Allogene 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. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.