Associate Director, Translational Operations

AstraZeneca's Oncology R&D division is dedicated to pioneering the treatment, prevention, and modification of complex diseases. As part of our mission, we are looking for an Associate Director, Translational Operations to play a pivotal role in handling vendor relationships and clinical biospecimen operations, overseeing logistics and analysis of Human Biological Samples (HBS) within our clinical trial programs, with special focus on cell therapy clinical trials. You will be based in Santa Monica, CA and will report to the Director, Translational Operations.

1. Lead biosample operations for cell therapy clinical trials, supporting clinical operations and handling external vendors to ensure high-quality and budget-compliant biospecimen logistics and analysis.
2. Oversee HBS logistics from trial sites to analytical labs, ensuring sample integrity and traceability, and compliance with contracted timelines.
3. Be the primary contact for operational vendor management, collaborating with scientific teams on vendor selection, onboarding, and integration.
4. Negotiate and execute contracts (e.g., Master Services Agreements, Scope of Work/Work Orders, Data Transfer Agreements, etc.) working cross-functionally with Clinical, Data Management, Legal, Procurement, and Finance teams.
5. Develop and implement systems for sample tracking, record-keeping, and quality assurance, ensuring receipt and accessioning of samples, partnering with third-party laboratories for analysis and data transfer.
6. Collaborate with program teams to maintain development plans, assess risks, and implement corrective actions. Troubleshoot and resolve issues with sample collection, processing, storage, and shipment in collaboration with Clinical Operations, CROs, and vendors.
7. Lead meetings, track action items, and ensure timely execution of follow-up actions, ensure compliance with AZ guidelines and contribute to clinical/regulatory documentation.

1. BS with at least 8 years, MS with 5 years and PhD with 3 years of relevant experience in biospecimen management, clinical research, or translational operations.
2. Experience in vendor management, contract negotiation, and human biosample logistics within clinical trials.
3. Familiarity with LIMS (Laboratory Information Management Systems) and experience with biomarker assays, pharmacokinetic analysis, and related laboratory techniques.
4. Ability to lead cross-functional teams and handle multiple priorities in a fast-paced environment.
5. Effectively collaborate with teams and present findings to both technical and non-technical partners.