Director, Translational Operations

Allogene Therapeutics•South San Francisco, CA

8h•Hybrid

About The Position

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).

Requirements

Bachelor’s 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.

Nice To Haves

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.

Responsibilities

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 cross‑functional 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.