Associate Director, Clinical Supply Logistics & Distribution — Cell Therapy

AstraZeneca•Gaithersburg, MD

About The Position

AstraZeneca is building an ambitious Cell Therapy portfolio focused on allogeneic and in vivo programs. These off-the-shelf therapies are designed to be manufactured at scale, inventoried, and delivered on demand, requiring a clinical supply model that can expand patient access reliably and compliantly. The Associate Director, Clinical Supply Logistics and Distribution — Cell Therapy supports development of the global clinical supply strategy and operating model for these programs. The role spans supply architecture and distribution network design through order fulfillment and delivery to clinical sites. Working with the Executive Director, Patient Supply Operations, Clinical Operations, CMC, Manufacturing, Quality, Regulatory, external logistics providers, and other partners, this role translates clinical development plans into reliable, compliant, and scalable supply solutions. The Associate Director leads key elements of the operating model, establishes fit-for-purpose processes, and helps ensure trial participants receive therapy reliably and on time. The role also contributes to the development of capabilities and standards for delivering off-the-shelf cell therapies worldwide and supports transition planning from clinical to commercial supply.

Requirements

Bachelor’s degree in supply chain, Life Sciences, Engineering, Business Administration, or a related field.
At least 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; biologics, vaccines, gene therapy, cell therapy, or specialty pharmaceutical experience is preferred.
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, including 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 development of the strategic vision and end-to-end clinical supply operating model for 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.
Develop and maintain program- and study-level clinical supply strategies, translating study designs, enrollment forecasts, pipeline progression, and manufacturing constraints into integrated supply plans with assumptions, scenario planning, and risk mitigations.
Lead clinical supply execution from study startup through completion, ensuring uninterrupted investigational medicinal product delivery to patients across active sites and geographies.
Establish and operate order management and fulfillment processes, including demand signals, allocation logic, release-to-ship workflows, inventory replenishment, site coordination, delivery confirmation, and escalations.
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 with Clinical Operations to provide supply recommendations, risks, mitigations, and decisions for Global Study Teams and leadership.
Integrate clinical supply timelines into study startup plans, site activation milestones, and enrollment projections.
Oversee third-party clinical packaging and labeling activities, including country-specific requirements and timelines supporting regulatory submissions and study milestones.
Support clinical site enablement through site feasibility, import pathway confirmation, lane qualification, site delivery requirements, and development of training materials.
Implement exception management and escalation processes to enable rapid triage of supply disruptions, cross-functional response, 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 toward registration and potential commercialization.
Represent clinical supply logistics in 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.