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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 managing 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.
Responsibilities:
Lead biosample operations for cell therapy clinical trials, supporting clinical operations and managing external vendors to ensure, high-quality and budget-compliant biospecimen logistics and analysis.
Oversee HBS logistics from trial sites to analytical labs, ensuring sample integrity and traceability, and compliance with contracted timelines.
Be the primary contact for operational vendor management, collaborating with scientific teams on vendor selection, onboarding, and integration.
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.
Develop and implement systems for sample tracking, record-keeping, and quality assurance, ensuring receipt and accessioning of samples, partnering with third-party laboratories to meet deadlines for analysis and data transfer.
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.
Lead meetings, track action items, and ensure prompt execution of follow-up actions, ensure compliance with AZ guidelines and contribute to clinical/regulatory documentation.
Education and Experience:
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.
Experience in vendor management, contract negotiation, and human biosample logistics within clinical trials.
Familiarity with LIMS (Laboratory Information Management Systems) and experience with biomarker assays, pharmacokinetic analysis, and related laboratory techniques.
Ability to lead cross-functional teams and manage multiple priorities in a fast-paced environment.
Effectively collaborate with diverse teams and present findings to both technical and non-technical partners.
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The annual base salary for this position ranges from $129,000 to $193,000. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Date Posted
20-Dec-2024Closing Date
14-Feb-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.