Director, CTCO Start Up Site Management and Monitoring (SMM), Cell Therapy

Location: Barcelona, Spain (on-site: 3 days/week working from the office)

The Director, CTCO Start Up Site Management and Monitoring (SMM) – Cell Therapy is responsible for delivering Cell Therapy clinical interventional studies in their region. In this role, you will lead and manage resources assigned to clinical trials, oversee budgets and timelines, and support implementation aligned with local regulations and international GCP and GMP guidelines. You will also ensure the effective chain of custody between clinical sites, manufacturing, apheresis, and patient care within defined timeframes and quality standards.

As the Director, SSU, you will be part of the Cell Therapy SMM Leadership Team and line manage dedicated groups of staff. You will ensure clear communication to the Global Head SMM on any risks to study performance, feasibility assessment, enrolment, and mitigation plans impacting program delivery.

Typical Accountabilities
Team leadership: Lead a dedicated Cell Therapy group, build team engagement, and develop team style and behavior.
Cross-functional collaboration: Work across multiple TA functions in AstraZeneca to foster strong partnerships and collaboration.
Operational partnership: Partner across operations teams to drive efficient patient outcomes through high-quality standards of patient care and reduced bottlenecks.
Resource assurance: Ensure adequate resources for Cell Therapy studies assigned to the region.
Workforce adequacy: Ensure the team’s resources are adequate and aligned to demand.
Performance management: Lead team development and performance management.
Coaching: Coach team members and direct reports regularly; plan and organize external coaching where needed.
Feasibility and enrolment: Contribute to high-quality feasibility assessments and delivery of country enrolment projections.
Study delivery: Oversee successful delivery of Cell Therapy SMM targets at country and regional levels to plan, with speed and quality, including supporting local implementation and optimization of AstraZeneca’s digital strategy.
Budget management: Deliver regional and country-level budgets to plan with agreed RBU targets.
Quality improvement: Contribute to continuous improvement of study processes and related procedures.
Systems upkeep: Ensure all systems are continuously updated.
Inspection readiness: Ensure completeness and timeliness to maintain sites as “Inspection Ready.”
Study support: Assist Local Study Managers/teams with feasibility, timeline forecasting, resources, recruitment, and study materials.
Issue resolution: Provide direction to LSM/teams on major study commitments, including resolving key issues.
SMM initiatives: Support SMM initiatives and activities as agreed with the Cell Therapy SMM Global Head.
Medical collaboration: Ensure collaboration with global Field Clinical Advisors and local Medical Affairs.
Compliance: Ensure Cell Therapy study activities at country level comply with local policies and codes of ethics.
Technology adoption: Collaborate with Technology and AI teams, modeling behaviors of adoption and innovation.
Vendor management: Build and maintain partnerships with CROs and vendors delivering Cell Therapy studies in the region.
Essential Skills
Education: Bachelor’s degree in a related discipline (preferably life sciences) or equivalent qualification.
Experience: Minimum 7 years as a leader in Development Operations or related fields.
Technical expertise: Strong technical background and extensive clinical operations experience.
Line management: Previous line management experience.
People development: Proven team building and organizational development skills.
Interpersonal skills: Excellent interpersonal capabilities.
Change leadership: Positive approach to managing change for self, team, and business; views change as an opportunity to improve performance and add value.
Project management: Proven project management experience.
Organizational excellence: Excellent organizational, analytical, influencing, and negotiation skills; able to build strong site partnerships to optimize patient outcomes.
Communication: Excellent presentation and communication skills, both verbal and written.
Decision-making: Strong decision-making and cross-functional team-building skills.
Resource and financial management: Excellent resource and financial management skills.
Attention to detail: Strong attention to detail combined with effective delegation and prioritization.
Language and IT: Excellent spoken and written English; good ability to learn and adapt to working with IT systems.
Travel: Ability for national and international travel.
Desirable for the Role
Process and guidelines: Very good knowledge of the Clinical Study Process, Procedural Documents, and international GMP-ICH-GCP guidelines.
Therapeutic experience: Past experience in CAR therapies.
Monitoring: Excellent knowledge of the Monitoring Process.
Study operations: Good understanding of Study Drug Handling and Data Management processes.
Regulatory: Good knowledge of relevant local and international regulations.
Medical knowledge: Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
Operational excellence: Ability to champion more efficient and effective methods/processes to deliver quality clinical trials with reduced budget and shorter timelines.
Remote collaboration: Ability to work effectively with remote collaborators.
Integrity: High ethical standards.
Conflict and crisis management: Good conflict management skills and ability to handle crises.
Intercultural awareness: Strong intercultural awareness.
Global standards: Excellent ability to work according to global standards.