Study Start-Up Associate Director - Cell Therapy

About the role

AstraZeneca is looking for a Study Start-Up Associate Director (SSU AD) for its Cell Therapy programme in Barcelona, Spain. The role organises, oversees and controls the regulatory and ethics committee (EC) start-up processes for clinical trials run by Site Management & Monitoring (SMM) at country level, ensuring activities follow agreed resources and timelines, AstraZeneca procedures, ICH-GCP and local regulations. It works 3 days in the office and 2 days from home.

Key responsibilities

• Lead and manage the Study Start-Up (SSU) team, set objectives, coach and develop the team, and report to the Director Country Head or Director Site Management & Monitoring.
• Plan resources for new projects across assigned therapeutic areas so that staffing is available at start-up.
• Provide project oversight for studies up to site activation, with effective resourcing and smooth handover.
• Guide Local Study Associate Directors and teams on best practices, resolve process issues and act as a key escalation point.
• Maintain guidelines, templates and procedural documents, drive process improvement and ensure compliance with local policies, regulations and the company code of ethics.
• Work with regional SMM initiatives and, where locally decided, support LSADs with timeline forecasting, oversee feasibility and feasibility-to-country-selection procedures, and provide project oversight across the study lifecycle.

Required profile

• Bachelor's degree in a related discipline, preferably life sciences, or equivalent qualification.
• Previous experience in the pharmaceutical industry, preferably in Clinical Operations (CRA / Sr.CRA / LSAD) or a related field.
• Knowledge of drug development and GxP processes, ICH-GCP, relevant country regulations and medical knowledge, with the ability to learn the AZ therapeutic areas.
• Fluent written and spoken business-level English; ability to travel nationally and internationally as required.

Required skills

• Clinical study operations (GCP) and quality management, including site selection and set-up.
• Project management and prioritisation.
• Team leadership in person and virtually, with active listening, problem solving and strategic thinking.