Associate Director Translational Operations

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AstraZenecas 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 highquality and budgetcompliant 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 recordkeeping and quality assurance ensuring receipt and accessioning of samples partnering with thirdparty 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 of followup 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 crossfunctional teams and manage multiple priorities in a fastpaced environment.

• Effectively collaborate with diverse teams and present findings to both technical and nontechnical partners.

#LIonsite #CellTherapy

The annual base salary for this position ranges from $129000 to $193000. However base pay offered may vary depending on multiple individualized factors including market location jobrelated knowledge skills and experience. In addition our positions offer a shortterm incentive bonus opportunity; eligibility to participate in our equitybased longterm 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 atwill 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.