Introduction to role:

The Local Study Associate Director, Feasibility Lead for Spain and Italy is a key part of the country Cell Therapy Site Management & Monitoring (SMM) organisation. This role supports the feasibility assessment and delivery of the early and late-development Cell Therapy Portfolio within the country, providing end-to-end oversight of feasibility activities for AstraZeneca internally delivered studies.

The role is responsible for leading Local Study Team(s) (LSTs) at the country level to deliver committed components of clinical studies according to agreed resources, budget, and timelines, ensuring compliance with AZ Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations.

This role requires significant experience and knowledge in developing local recruitment and retention Feasibility Strategies(s) (LSTs) at the country level to deliver committed components of clinical studies according to agreed resources, budget, and timelines, ensuring compliance with AZ Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations. It requires significant experience and knowledge in developing local recruitment and retention Feasibility Strategies, balanced with strong project management capabilities, strategic thinking, data analytics/interpretation, and technical skills as well as a good understanding of country landscape and priorities.

In addition to feasibility responsibilities, the LSAD – Feasibility may be requested to undertake local study leadership activities at country level, supporting the delivery of clinical studies within agreed resources, budget, and timelines, and in compliance with AZ procedural documents, international guidelines (e.g., ICH-GCP), and local regulations. These activities may span site identification, qualification, set-up, initiation, monitoring oversight, and closure.

Accountabilities:

• Accountable to Senior Director Feasibility Cell Therapy who sets the Feasibility Strategy Globally from design feasibility through operational feasibility and study baseline/re-baseline.

• Responsible for leading end to end activities for Spain and Italy and acting as single point of contact for all stages of the local feasibility assessment operations ensuring actionable feedback for their country that enables optimal study design, site selection, manging right country/site allocation, and recruitment forecast baseline for start-up.  

• Serve as Subject Matter Expert for feasibility and recruitment in the country, and expert user for study design and planning digital platforms, including oversight and training of SMM country’s users (LSADs, S/DSMM).

Typical activities include but not exhaustive:

• Contribute to the design remit and study specification validation by identifying country-specific challenges

• Identify any conflicts with clinical standard of care, provide transparency on key delivery challenges identified by investigator feasibility responses and targeted competitive landscape and trends discussions with Medical Affairs

• Leverage AstraZeneca/competitor performance data to build realistic, cost-efficient sustainable recruitment targets and strategies, provide early transparency on recruitment strategies (ie, utilization of recruitment or site identification vendors, site-specific recruitment tools, etc.).

• Creating feedback for country in collaboration with the SMM Leadership Team and other key stakeholders (Site Partnerships or Field Clinical Advisers as applicable and/or Medical Affairs) and discussing critical points directly with Global Feasibility and the Global Project Team

• Identify, follow-up and share with country SMM Leadership Team (LT) early pipeline information or project updates to allow early country planning and frontloading SMM input.

• Manage, validate and deliver the country SMM feasibility responses for internal studies on time, with quality, to meet study planned LSI milestone, Patient Recruitment Framework recommendations and any other Global Medicines Development patient recruitment objectives

• Lead the development of robust country-specific and site-specific recruitment and retention strategies that capitalize on feasibility findings and align with realistic, resource efficient, cost-effective recruitment and retention strategies and plans.  Collaborate with stakeholders across SMM (LSADs, SMM LT and CRAs) to contribute to the development of study-specific risk management and mitigation plans, and study-specific contingency planning, escalation and action implementation plans for internal studies.

• Ensure transition of country-specific feasibility knowledge acquisitions by transferring key data to the local study team at the local study handover meeting.

• Support and drive global and local feasibility, recruitment and retention process improvement and simplification initiatives.

• Maintains awareness of marketplace activities, policies, trends, technology and information affecting the business and organization to support continued improvement of clinical recruitment efforts adhering to company policies

• Champion recruitment and retention practices, process improvement within Clinical Operations and collaborate with internal stakeholders to facilitate knowledge transfer and best practices

• Participate in training and mentoring of new members of the local study teams ensuring compliance with ICH/GCP and AZ Procedural documents.

• Where needed, LSAD tasks and accountabilities may include activities listed under the LSAD JD accountabilities.

• Local Study Leadership (as assigned): Lead country-level study delivery activities — site identification through closure — in partnership with the local study team, ensuring compliance with AZ procedures, ICH-GCP, and local regulations, and delivery to agreed time, cost, and quality (reference LSAD JD for details).

Essential Skills/Experience:

• Bachelor’s degree in relevant field (e.g. life sciences, business management, or project management) or project management certification.

• Significant experience (~5 years) in pharmaceutical industry drug development processes.

• Fluency in Spanish and English is required.

• Proven experience in managing, influencing, building and maintaining relationships, and achieving results with senior stakeholders in conflicting priority environment.

• Proven experience in developing and delivering study delivery strategies and tactical/operational plans aligned to commercial and regulatory objectives.

• Clinical trial patient and investigator recruitment and retention experience.

• Proven experience in project and budget management.

• Excellent written and verbal communication skills, negotiation, collaboration, and interpersonal skills.

• Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.

• Good knowledge of relevant local regulations.

• Good medical knowledge in relevant AZ Therapeutic Areas.

• Good understanding of Clinical Study Management including monitoring, study drug handling and data management.

• This is a field-base role, so ability to travel is required, approximately 30%

• Ability to deliver quality according to the requested standards.

• Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.

• Good analytical and problem-solving skills.

• Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.

• Good cultural awareness.

• Ability to understand the impact of technology on projects and to use and develop skills while making appropriate use of systems/software in an e-enabled environment.

• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.

Desirable Skills/Experience:

• Ability to work in an environment of remote collaborators.

• Fluency in Italian is preferred.

• Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.

• New product development experience within the pharmaceutical industry

• Prior involvement in developing study delivery strategies and tactical/operational plans aligned to local regulatory objectives.

• Proven project management or other complex/cross-border management experience

• Proven experience working with partners, Clinical Research Organizations (CRO) and Academic Research Organizations (ARO)

• Experience in cell therapy.

• Ability to influence strategically and persuade tactfully, to obtain desired outcomes while maintaining effective, positive, organizational relationships

• Process Innovation Mindset: Ability to critically evaluate current workflows and identify opportunities where AI can drive efficiency, quality, or innovation

Why AstraZeneca: Here, you will join a collaborative scientific community where industry speed meets academic rigor to push the frontiers of cancer care. We unite diverse experts across countries and leading medical centers, pair cutting-edge platforms with real-world data, and empower people at every level to take smart risks and learn fast. You will see your feasibility insights shape pivotal decisions, gain exposure across global teams, and grow in a culture that values curiosity, clarity, and kindness as much as ambition—so the work you lead can translate into meaningful impact for patients.

Call to Action: If you are ready to shape country feasibility across Spain and Italy and turn bold ideas into predictable delivery, send your application today to help us accelerate the promise of cell therapy!

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.