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

AstraZeneca•Gaithersburg, MD

8d•Hybrid

About The Position

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?

Requirements

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.

Nice To Haves

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.

Responsibilities

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.
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.
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.
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.
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.
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.
Review protocols and study-level operational materials to align with cell therapy patient operations requirements, administration standards, technical constraints, and guidelines.
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.
Act as an expert reviewer for study support materials and operational documentation that reference patient operations, product handling, administration, or key patient journey achievements.
Capture lessons learned, identify process gaps, and embed standards across the cell therapy portfolio to drive ongoing improvement and organizational learning.

Benefits

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.
Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking.
We’re curious about science and the advancement of knowledge.
We find creative ways to approach new challenges.
We’re driven to make the right choices and be accountable for our actions.
As an organisation centred around what makes us human, we put a big focus on people.
Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab.
Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential.
Here, you’ll do work that has the potential to change your life and improve countless others.
And, together with your team, you’ll shape a culture that unites and inspires us every day.
This is your life at AstraZeneca.