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

The Senior Director, Regional Site Management and Monitoring (SMM) Cell Therapy delivers 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 Sr. Director, you will be part of the Cell Therapy SMM Leadership Team and line manage a dedicated group(s) of staff. You will also ensure that the Executive Director, Global Head SMM is informed of any risk to study performance, feasibility assessment, enrollment and mitigation of risk to delivery of the programs.

Desirable for the role

• Demonstrated knowledge of the Clinical Study Process, Procedural Documents and international GMP-ICH-GCP guidelines.

• Experience in CAR therapies

• Excellent knowledge of the Monitoring Process.

• Understanding of the Study Drug Handling Process and the Data Management Process.

• Knowledge of relevant local and international regulations.

• Medical knowledge and a learning mindset

• Look for efficient methods/processes of delivering quality clinical trials with reduced budget and in less time.

• Work in an environment of remote collaborators in a and global environment according to global standards

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 of 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 and ensure all systems are updated.

• Ensure completeness 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 issues identified.

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

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

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

• Demonstrated Technical and clinical operations and Project Managementt experience.

• Previous line management experience with team building and people/organizational development skills.

• Manage change with a for self, team and business. See change as an opportunity to improve performance and contribute to business.

• Build partnerships with sites to improve patient outcomes

• Excellent resource management skills, good financial management skills.

• Ability for national and international travel.

Benefits offered include:

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