Study Start Up Associate Director - Cell Therapy

Location: Barcelona - Spain (3 days working from the office and 2 days working from home)

Introduction to the role

The Study Start-Up Associate Director (SSU AD) is responsible for organizing, overseeing, and controlling the regulatory and ethics committee (EC) start-up processes for clinical trials conducted by Site Management & Monitoring (SMM) at the country level. This role ensures all start-up activities are executed according to agreed resources and timelines, and in full compliance with AstraZeneca procedures, international guidelines such as ICH-GCP, and all relevant local regulations. The SSU AD leads and manages the Study Start-Up (SSU) team, setting clear objectives, and conducting ongoing performance management and follow-up, reporting to Director Country Head or /Director Site Management & Monitoring. The SSU AD provides leadership and direction for regulatory and Ethics Committee submissions and coordinates other start-up related activities as locally agreed. The SSU AD is also accountable for driving continuous improvement in start-up processes and for establishing and maintaining high quality standards across all AstraZeneca internally managed studies.

Typical Accountabilities

Accountabilities for this role include:

• Ensure effective resource planning for new projects across assigned Therapeutic Areas within the local SMM team to allow timely staffing during the study start-up phase.
• Oversee the performance development of the Study Start-Up (SSU) team, providing guidance and regular development activities as needed.
• Deliver ongoing coaching and support to the SSU team and assist Local Study Associate Directors (LSADs) and Local Study Teams during study start-up, ensuring optimal team capability.
• Contribute to regional SMM initiatives and activities as appropriate, aligning start-up practices with broader organizational goals.
• Ensure that all activities performed by the SSU team at the country level are fully compliant with local policies, regulations, and the company code of ethics.
• Provide comprehensive project oversight for studies up to site activation, focusing on effective resourcing and smooth handover.
• Offer direction to LSADs and SSU team members regarding best practices during study start-up, resolving process issues as they arise.
• Act as a key escalation point to help resolve complex issues related to study start-up activities.
• Serve as the local process owner for study start-up, maintaining guidelines, templates, procedural documents, and driving continual process improvement.
• Demonstrate excellent knowledge of the local clinical trial environment, working externally with stakeholders to influence and optimize start-up processes.

Note: Some responsibilities may also be shared with SMM Directors. Where locally decided, additional responsibilities may include:

• Supporting LSADs with forecasting study timelines.
• Providing or supporting project oversight throughout the entire life cycle of studies.
• Overseeing the local feasibility process from initial assessment through to country selection and ensuring robust procedures for feasibility activities in the BioPharma portfolio.

Education, Qualifications, Skills and Experience

Education and experience:

• Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification aligned to the knowledge and skills of the role and ensures successful conduct of responsibilities and appropriate interactions with internal and or external stakeholders.
• Previous experience in the pharmaceutical industry, preferably in Clinical Operations (CRA / Sr.CRA / LSAD) or other related fields.

Relevant knowledge and ability to fulfil key responsibilities, including but not limited to:

Drug development process and related GxP processes, International guidelines ICH-GCP, relevant country regulations, medical knowledge and ability to learn relevant AZ Therapeutic Areas, Clinical Study Management including study start-up and stakeholder partnering.

Role-Required Skills:

• Personal Effectiveness & Drives Accountability in Others
• Learning Agility
• Financial, Technology & Process Competency
• Active Listening, Fluency in written & spoken business-level English
• Act with Integrity & high ethical standards • Effectively lead a team across in-person and virtual settings to deliver shared goals, demonstrates cultural awareness
• Identify and champion more efficient delivery of quality clinical trials with optimised cost and time
• Ability to travel nationally/internationally as required
• Communication & Teamwork - Influencing, Collaboration, Impactful Site conversations
• Effective, risk-based thinking - Plans & Aligns, Strategic thinking, Problem Solving, Critical Thinking, Decision Making, Effective Issue Management
• IMP Development & Regulation - Study vendor & Biosample oversight
• Clinical Study Operations (GCP) & Quality Management - Study site selection & set-up
• Deliver Priorities Results & Impact - Project Management, Deliver Results.

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.