AstraZeneca

Associate Director, Cell Therapy Patient Operations Processes, Standards, and Excellence

AstraZeneca  •  Gaithersburg, MD (Onsite)  •  3 hours ago
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Job Description

Are you ready to turn innovative cell therapy science into reliable, patient-ready operations that scale? In this role, you will shape how patients safely and seamlessly move through the cell therapy journey—from apheresis to administration—by building the standards and processes that teams and treatment centers rely on every day. Your work will help reduce operational risk, speed study execution, and enable patients to access life-changing medicines sooner.

You will join a focused oncology team with the ambition to prevent cancer from taking more lives. Working across clinical and commercial programs, you will lead the development of practical, compliant, and scalable operational standards that bring consistency to complex workflows across diverse sites and healthcare settings. Can you align cross-functional teams behind clear, high-quality standards and ensure every site is ready on day one?

Accountability

Standards and Documentation:

Develop, author, review, and maintain fit-for-purpose standards, processes, manuals, site-facing forms, and training materials that enable safe, compliant, and effective patient operations and clinical product administration.

Subject Matter Expertise:

Serve as the internal SME for cell therapy field and patient operations, including product handling and administration practices, ensuring consistent, lifecycle-appropriate execution at treatment centers.

Cross-Functional Integration:

Partner with Patient Operations, Clinical Operations, Clinical Development, Quality, Manufacturing, Supply Chain, Medical, and Regulatory to define, implement, and sustain robust operational standards and center-facing documentation across the end-to-end patient journey.

Study and Commercial Readiness:

Support study startup, ongoing execution, and commercial readiness by making sure patient operations processes, administration requirements, and product handling documents are clear, consistent, and delivered to timeline.

Process Excellence:

Lead and contribute to initiatives that improve execution quality, scalability, and consistency across cell therapy clinical operations, with a focus on patient journey coordination and site readiness.

Issue and Quality Support:

Provide expert support during issue resolution and quality events, including clinical incidents, operational deviations, inspections, audits, and root cause analyses related to patient operations and administration practices.

Protocol and Materials Review:

Review protocols and study-level operational materials to align with cell therapy patient operations requirements, administration standards, technical constraints, and guidelines.

Training and Enablement:

Train and support internal study teams and site-facing functions on patient coordination, product care, office management practices, and operational standards; support or conduct site training as needed.

Expert Review and Governance:

Act as an expert reviewer for study support materials and operational documentation that reference patient operations, product handling, administration, or key patient journey achievements.

Continuous Improvement and Knowledge Sharing:

Capture lessons learned, identify process gaps, and embed standards across the cell therapy portfolio to drive ongoing improvement and organizational learning.

Essential Skills/Experience

  • Bachelors in related scientific, clinical, or healthcare profession, or equivalent
  • Minimum 5 years of experience in hematology, oncology and/or autoimmune including autologous and allogeneic cell therapy workflows
  • Extensive experience in development and implementation of SOPs, Manuals, Guidelines, and training documents/modules for cellular therapies in clinical research, treatment center, clinical development, patient operations, or related pharmaceutical/biotech functions.
  • Experience working across a global matrix environment, partnering with cross-functional teams such as Patient Operations, Clinical Operations, Clinical Science, Manufacturing, Supply Chain, Quality, and Medical.
  • Strong knowledge of clinical trial design, GCP principles, drug development, and operational execution requirements in complex clinical studies.
  • Demonstrated ability to translate technical concepts into clear operational processes and standards that are practical for study teams and investigational sites.
  • Excellent written and verbal communication skills, with the ability to explain highly technical information clearly to a range of audiences.
  • Strong problem-solving, judgment, and organizational skills, with the ability to lead complexity and influence across functions.
  • Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint.

Desirable Skills/Experience

  • Advanced degree in related scientific, clinical, or healthcare profession, or equivalent
  • Minimum 3 years of experience in hematology, oncology and/or autoimmune including autologous and allogeneic cell therapy workflows
  • Experience with site training, study startup, and patient journey design/execution in complex clinical trials.
  • Ability to work in an environment of remote collaborators.
  • Integrity and high ethical standards.
  • Good conflict leadership skills and ability to handle crisis.
  • Good intercultural awareness.
  • Experience supporting or contributing to deviation management, inspection readiness, audit support, quality events, and process improvement initiatives.

When we put unexpected teams in the same room, we spark bold thinking with the power to inspire life-changing medicines! In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our outstanding and ambitious world.

Why AstraZeneca

Here you will work shoulder to shoulder with scientists, clinicians, engineers, and operators to translate breakthrough ideas into therapies for patients with cancer. We move decisively, pairing cutting-edge science with modern technology and the resources to scale, so your standards and processes will be put to work across studies quickly and visibly. We value kindness alongside ambition, and we empower people at every level to lead, ask bold questions, and take smart risks that accelerate progress for patients and for your career.

Step into a role where your operational leadership turns complex cell therapies into dependable patient care—make your impact with AstraZeneca today!

Date Posted

25-Jun-2026

Closing Date

Our 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.

AstraZeneca

About AstraZeneca

We're transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet. For more information, visit www.astrazeneca.com.

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Industry
Chemicals & Materials
Company Size
10,000+ employees
Headquarters
Cambridge, GB
Year Founded
Unknown
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