Director, Translational Operations

About Allogene:

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.

About the role:

Allogene is seeking a Director Translational Operations to provide strategic and hands-on leadership for biospecimen operations across Allogene clinical programs. This individual will oversee internal FTEs and external vendors responsible for biospecimen collection kitting shipping receipt accessioning storage chain-of-custody and sample analysis (e.g. central labs specialty assay vendors biorepositories couriers and kit providers). The ideal candidate thrives in a fast-paced and dynamic environment can roll up their sleeves and brings deep expertise in operationalizing translational sample workflows to enable high-quality analyzable clinical and biomarker data.

The Director Translational Operations will report to the Vice President of Research and Translational Science and will partner closely with Translational Sciences Clinical Operations Clinical Development Biometrics/Data Management Quality Regulatory and external collaborators to ensure robust scalable and inspection-ready sample operations that enable high-quality biomarker and translational readouts. This is a hybrid role based at our headquarters in South San Francisco CA (US based remote may be considered as well for candidates outside of the area).

Responsibilities include but are not limited to:

• Own the end-to-end biospecimen operational strategy for clinical studies ensuring feasibility scalability quality and timeline alignment from protocol design through database lock and long-term storage.
• Lead internal teams and external vendors dedicated to biospecimen workflows including vendor selection qualification oversight performance management and issue escalation.
• Partner cross-functionally to integrate biospecimen requirements into protocols lab manuals informed consent language and operational plans.
• Develop and maintain sample lifecycle process maps (collection shipment receipt processing storage analysis data transfer) including clear roles and responsibilities across Allogene and vendors.
• Oversee kit design and distribution site training materials and operational guidance to enable consistent high-quality collections across domestic and ex-US sites.
• Establish and monitor KPIs/KQIs for biospecimen operations (e.g. collection compliance shipment timeliness temperature excursions sample integrity query/issue rates assay turnaround time vendor data delivery).
• Own chain-of-custody labeling standards reconciliation deviations and CAPA processes for biospecimens including systematic root-cause analysis and prevention.
• Ensure inspection-ready operations consistent with applicable GxP/GCLP principles internal procedures and vendor quality agreements; support audits and inspections as needed.
• Drive vendor governance (standing meetings performance reviews risk registers forecast alignment and change control) ensuring vendors deliver to SOW quality expectations and timelines.
• Own and maintain budgets and forecasts for translational/biospecimen operations; partner with Finance/Procurement on contracting and invoice/PO processes as applicable.
• Enable robust data flow and traceability by coordinating vendor deliverables (e.g. manifests accessioning logs LIMS exports assay result files) and ensuring timely high-quality transfer to Allogene systems/partners.
• Provide crossfunctional operational support to enable efficient execution of Translational Science activities across multiple programs
• Mentor and develop team members supporting translational operations; provide guidance to assess and resolve operational project issues; contribute to staffing plans and capability building.
• Perform other duties as assigned.

Position Requirements & Experience

• Bachelors degree required in life sciences bioengineering clinical research or a related field; advanced degree preferred with at least 10 years of relevant industry experience in translational operations clinical sample operations central lab operations clinical laboratory services or biomarker operations with at least 5 years in a leadership role.
• Demonstrated expertise building and running biospecimen operational workflows across multi-site clinical trials including collection logistics cold-chain shipping biorepository operations and specialty assay vendor oversight.
• Strong working knowledge of clinical research operations and expectations for sample handling integrity traceability and documentation; experience supporting early to late-stage trials preferred.
• Proven ability to select manage and hold vendors accountable through SOWs KPIs governance and continuous improvement.
• Excellent organizational skills and an ability to prioritize effectively to deliver results within established timelines and budgets.
• Strong interpersonal written and verbal communication skills; able to collaborate effectively across functions and with senior stakeholders.
• Comfortable in a fast-paced environment with evolving priorities; pragmatic problem solver with high ownership and follow-through.
• Willingness and ability to travel domestically and internationally as required.
• Candidates must be authorized to work in the U.S.

Preferred Qualifications

• Experience in cell therapy and/or oncology clinical trials including complex sample handling and time-sensitive logistics.
• Experience with global sample operations (ex-US shipping import/export documentation courier qualification regional lab networks).
• Familiarity with LIMS/data interfaces and operationalizing biomarker data transfers into clinical databases or analytics environments.
• Experience partnering with Quality on vendor audits quality agreements QMS expectations and inspection readiness.

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 $200000 - $230000 per year. 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 designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.

#LI-REMOTE #LI-TF1