Director, Regional Site Management and Monitoring (SMM) Cell Therapy

The Director, CTCO Startup Site Management and Monitoring (SMM) Cell Therapy has to deliver the Cell Therapy clinical interventional studies in their region. You will lead the resources assigned to the clinical trials. You will oversee the budgets and timelines and support implementation using local relevant local regulations and

international GCP and GMP guidelines. As well, you will manage the chain

of custody between clinical sites, manufacturing, apheresis and back to patient care within time frames and quality standards

As the Director, SSU you will be part of the Cell Therapy SMM Leadership Team and line

manage a dedicated group(s) of staff. You will also ensure to the inform the

Global Head SMM of any risk to study performance, feasibility assessment, enrollment and mitigation of risk to delivery of the programs.

You Will:

• Lead dedicated Cell Therapy group, building the team engagement, developing team style and behavior.

• Work across the multiple TA functions in AstraZeneca to ensure partnership and

• collaboration

• Partner across operations teams to ensure efficient patient outcomes through patient care with limited bottlenecks.

• Ensure resources for the Cell Therapy studies assigned to the region.

• Ensure that the resources of the team(s) is adequate.

• Development and performance management of the team. Coach the team members and all direct reports, and plans/organizes coaching with external providers.

• Contribute to high-quality feasibility work and delivery of established country enrollment projections.

• Oversee delivery of Cell Therapy SMM study delivery country and regional level targets to plan, with speed and quality (includes supporting the local implementation and optimization of AstraZeneca's digital strategy)

• Deliver regional and country level budget to plan with agreed RBU targets

• Contribute to the quality improvement of the study processes and other procedures.

• Ensure completeness and to maintain sites as “Inspection Ready”.

• Assist Local Study Managers/teams in study feasibility, forecasting study timelines,

• resources, recruitment, and study materials

• Direct LSM/teams on major study commitments including resolving any important issues identified.

• Support SMM programs/activities as agreed with Cell Therapy SMM Global Head.

• Ensure collaboration with global Field Clinical Advisors and local Medical Affairsteam.

• Ensure that the Cell Therapy study activities at country level comply with local policies and code of ethics. With collaborations across Technology and AI teams, model behaviors of adoption and new ideas.

• Develop partnership with CRO and vendors delivering in CT studies in the region

You Have:

• Bachelor's degree in related discipline in life science, or equivalent qualification

• Minimum 7 years of experience as a leader in Development Operations or other related fields.

• Technical and clinical operations experience with Previous line management experience.

• Team building and people/organizational development skills.

• Build partnerships with sites to increase patient outcomes

• Ability for national and international travel.

• Very knowledge of the Clinical Study Process, Procedural Documents andinternational GMP-ICH-GCP guidelines.

• Experience in CAR therapies and knowledge of the Monitoring Process.

• Experience with the Study Drug Handling Process and the Data ManagementProcess.

• Knowledge of relevant local and international regulations.

• Good medical knowledge and.

• Look for and promote more efficient methods/processes ofdelivering quality clinical trials with reduced budget and in less time.

• Work in an environment of remote collaborators.

• Good conflict management skills and ability to handle crisis.

Benefits offered include:

• A qualified retirement program [401(k) plan]

• Paid vacation, holidays, and paid leaves

• Health benefits including medical, prescription drug, dental, and vision coverage following the terms and conditions of the applicable plans.

#Celltherapy #LI-remote

Date Posted

12-Nov-2025

Closing Date

29-Nov-2025

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 embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.