Director, Site Management and Monitoring (SMM) Cell Therapy

AstraZeneca • Wilmington, DE

32d • $162,000 - $243,000 • Remote

About The Position

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

Requirements

• 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.

Responsibilities

• 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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees