Role at a glance
- Job function
-
Supply Chain, Procurement & Trade Supply Chain Planning & Logistics
- Salary
- Not yet verified Check the description for pay details; an amount or pay period has not been verified.
- Location
- Gaithersburg, Maryland, United States
- Employment
- Full-time
- Experience
- 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.
- Education
- Bachelor’s degree in supply chain, Life Sciences, Engineering, Business Administration, or a related field.
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Role Summary
The Associate Director will help develop and operate the global clinical supply model for off-the-shelf allogeneic and in vivo cell therapy programs. The role coordinates supply planning and execution across study teams, internal functions, and external logistics partners to support reliable delivery to clinical sites.
What You'll Do
- Develop program- and study-level supply strategies, translating study plans, enrollment forecasts, and manufacturing constraints into...
- Lead clinical supply execution from study startup through completion, including order management, allocation, replenishment, and...
- Coordinate distribution networks, depots, logistics providers, packaging, shipping, temperature monitoring, and import/export requirements.
- Support clinical site enablement through feasibility, import pathway confirmation, lane qualification, delivery requirements, and...
- Manage exception escalation and contribute to systems and process improvements for inventory visibility, order execution, and shipment...
- Partner on clinical-to-commercial supply transition planning and represent clinical supply in cross-functional forums.
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
Bachelor’s degree in a related field and 8+ years of clinical supply chain management experience, including global trial planning and execution in regulated environments. Qualifications also include clinical distribution and temperature-controlled supply expertise; knowledge of ICH-GCP, FDA, EMA, GDP, GMP, and applicable regulations; experience designing processes and systems; cross-functional collaboration; order fulfillment or order management experience; and work direction, mentoring, or people leadership.
Required
- 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.
Preferred
- 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.
Original job description
Content provided by the employer
Original job description
Content provided by the employer
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.
Key Accountabilities
- 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.
Essential Qualifications
- 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.
Desirable Skills/Experience
- 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.
#CellTherapy
The annual base pay for this position ranges from $115K to $173K. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
Date Posted
14-Oct-2026Closing Date
27-Oct-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
About the company
AstraZeneca
Large Enterprise
AstraZeneca is a global biopharmaceutical company dedicated to the research, development, and commercialization of innovative medicines. Headquartered in Cambridge, UK, the company focuses on areas such as oncology, cardiovascular, renal, metabolism, and respiratory diseases, striving to deliver life-changing treatments to patients. With a strong commitment to scientific excellence and collaboration, AstraZeneca invests in cutting-edge technologies and partnerships to drive advancements in healthcare. The company is also committed to sustainability and corporate responsibility, aiming to make a positive impact on communities worldwide.