Associate Director, Clinical Supply Logistics & Distribution — Cell Therapy

AstraZeneca•Gaithersburg, MD

1d•$115,000 - $173,000

About The Position

AstraZeneca is building one of the most ambitious Cell Therapy portfolios in the industry. Our allogeneic and in vivo programs represent the future of how these therapies will be delivered. Unlike patient-specific autologous treatments, these are off-the-shelf therapies designed to be manufactured at scale, inventoried, and delivered on demand. This model has the potential to dramatically expand patient access but requires a new clinical supply approach. We are seeking an experienced supply chain leader to help design and implement the global clinical supply model for these next-generation programs. The Associate Director, Clinical Supply Logistics and Distribution — Cell Therapy will support the development of the supply chain strategy and operating model for off-the-shelf cell therapy programs, from supply architecture and distribution network design through order fulfillment and site-level delivery. Working closely with the Executive Director, Patient Supply Operations, Clinical Operations, CMC, Manufacturing, Quality, Regulatory, external logistics providers, and other cross-functional partners, this role will translate clinical development plans into reliable, compliant, and scalable supply solutions. The Associate Director will lead key elements of the operating model, build fit-for-purpose processes, and ensure that every patient enrolled in our trials receives therapy reliably and on time. This is an opportunity to help establish the standards and capabilities for how off-the-shelf cell therapies reach patients worldwide.

Requirements

Bachelor’s degree in supply chain, Life Sciences, Engineering, Business Administration, or a related field.
8+ years of experience in clinical supply chain management, with increasing responsibility for global clinical trial supply planning, startup, and execution in complex, regulated environments.
Demonstrated experience leading clinical supply activities across multiple studies, geographies, or programs, preferably within biologics, vaccines, gene therapy, cell therapy, or other specialty pharmaceutical environments.
Experience with inventory-based, temperature-controlled clinical supply models, including demand planning, depot distribution, lane qualification, carrier oversight, import and export readiness, inventory visibility, cold chain logistics, and multi-country IMP delivery.
Working knowledge of clinical distribution networks and third-party logistics operating models, including depot strategy, distributor and 3PL governance, packaging and shipping configurations, carrier management, and temperature-controlled logistics for biological products.
Strong working knowledge of ICH-GCP, FDA, EMA, GDP, GMP, and applicable regulations governing clinical supply and IMP distribution.
Demonstrated ability to design and implement processes, operating procedures, systems requirements, governance structures, and documentation in evolving or newly established organizations.
Strong cross-functional collaboration and influencing skills, with experience working across Clinical Operations, CMC, Manufacturing, Quality, Regulatory, IT, and external partners.
Strategic and operational mindset, with the ability to translate program requirements into practical supply solutions and respond effectively to tactical issues that may affect patient dosing.
Experience with order fulfillment, order management, or order-to-cash processes for biologics, vaccines, or other inventory-based clinical or commercial supply models.
Experience providing work direction, mentoring, or people leadership within a matrixed or global organization.
Flexibility to support global time zones as needed.

Nice To Haves

Advanced degree, such as an MS or MBA.
Experience in cell therapy, gene therapy, ATMP, or advanced clinical biologics supply.
Experience with cryogenic or ultra-cold chain logistics for biological products.
Experience with trade compliance or the import and export of biological materials for clinical studies.
Supply chain certification, such as CSCP or CPIM.
Experience supporting late-phase clinical programs and clinical-to-commercial supply transition planning.
Experience presenting clinical supply strategies, risks, and investment recommendations to senior leadership or governance bodies.

Responsibilities

Support the development of the strategic vision and operating model for the end-to-end clinical supply chain across allogeneic and in vivo programs, including supply architecture, inventory positioning, clinical packaging and labeling, depot strategy, cold chain requirements, lane design, and site delivery models appropriate to each modality.
Develop and maintain clinical supply strategies at the program and study level, translating study designs, enrollment forecasts, pipeline progression, and manufacturing constraints into integrated supply plans with clear assumptions, scenario planning, and risk mitigations.
Lead clinical supply execution from study startup through study completion, ensuring uninterrupted investigational medicinal product delivery to patients across active sites and geographies.
Establish and operate the order management and fulfillment model, including demand signals, allocation logic, release-to-ship workflows, inventory replenishment, site coordination, delivery confirmation, and escalation processes.
Coordinate distribution network operations, including logistics provider governance, packaging and shipping configurations, regional depot partners, temperature monitoring, transit validation, and country-specific import and export requirements for biological materials.
Partner closely with Clinical Operations to provide supply recommendations, risks, mitigations, and required decisions to Global Study Teams and leadership. Ensure clinical supply timelines are integrated into study startup plans, site activation milestones, and enrollment projections.
Provide oversight of clinical packaging and labeling activities performed by third parties, including country-specific requirements and timelines supporting regulatory submissions and clinical study milestones.
Support clinical site enablement from a supply chain perspective, including site feasibility, import pathway confirmation, lane qualification, site-level delivery requirements, and development of training materials.
Implement exception management and escalation processes, enabling rapid triage of supply disruptions, cross-functional mobilization, and timely action to protect patient dosing.
Contribute to the technology and systems roadmap for off-the-shelf clinical supply operations, including inventory visibility, shipment and order execution, order tracking, milestone reporting, and exception alerting. Partner with IT and digital teams on implementation through enterprise systems, including SAP.
Drive continuous improvement and organizational learning by capturing lessons learned, developing scalable practices, and supporting the evolution of clinical supply capabilities as programs advance toward registration and potential commercialization.
Represent clinical supply logistics in relevant cross-functional forums, contributing operational insights to program planning, study governance, and portfolio decision-making.
Support the transition from clinical to commercial supply, partnering with Commercial Operations and other stakeholders on distributor engagement models, channel strategy, and site-of-care delivery frameworks.