Local Study Associate Director (LSAD), Cell Therapy (m/f/d) - Field Based

AstraZeneca · Hamburg

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In AstraZeneca's Cell Therapy division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. We have the potential to grow our pipeline and positively impact the lives of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. This role is part of the Oncology R&D team supporting the delivery of complex cell therapy clinical studies across sites.

We are looking for a

Local Study Associate Director (LSAD), Cell Therapy (m/f/d) - Field Based

The Local Study Associate Director (LSAD), Cell Therapy is a key member of the country Cell Therapy Site Management & Monitoring organisation. You will lead Local Study Team(s) at country level and be accountable for delivering committed components of clinical studies according to agreed resources, budget and timelines. This field-based role combines strategic study leadership with hands-on responsibility for site management, monitoring, feasibility, recruitment and retention. You will support clinical trial sites throughout the study lifecycle through regular on-site presence and ensure compliance with AstraZeneca Procedural Documents, ICH-GCP and relevant local regulations. The position requires approximately 55% travel, primarily within Germany, with occasional travel elsewhere in Europe and regular overnight stays.

Your Responsibilities:

• Lead Local Study Team(s) consisting of CRA(s) and CSA(s), coordinate activities and optimise team performance.
• Hold overall responsibility for country study commitments and the timely delivery of data to the required quality, budget and timelines.
• Provide end-to-end oversight of site identification, qualification, activation, initiation, management and close-out.
• Conduct Site Qualification Visits, Site Initiation Visits, routine Monitoring Visits, for-cause visits and Close-Out Visits, as required by the study and risk-based monitoring strategy.
• Maintain regular on-site presence at certified cell therapy centres and work closely with investigators, study coordinators and other site personnel.
• Identify clinical and operational risks early, agree mitigation actions with relevant stakeholders and follow them through to resolution.
• Lead or contribute to country and site feasibility activities and provide actionable input to study design, site selection, allocation and recruitment forecasts.
• Develop country-specific and site-specific recruitment and retention strategies using feasibility findings, performance data and the local competitive landscape.
• Ensure timely submission of required applications and documents to Ethics Committees/IRBs and Regulatory Authorities.
• Oversee country study budgets and support financial and contractual processes with clinical trial sites.
• Ensure the eTMF remains complete and inspection-ready and support audit, inspection and final archiving activities.
• Keep local and global stakeholders informed of progress, milestones, risks and key delivery challenges.
• Collaborate closely with international project teams, Medical Affairs, Site Partnerships and other internal functions.

Your Profile:

• Bachelor's degree in life sciences, medicine or a comparable field; an advanced scientific degree is advantageous.
• Approximately 5 years or more of experience in clinical research or pharmaceutical drug development.
• Several years of hands-on clinical study monitoring experience, including site qualification, initiation, routine monitoring and close-out activities.
• Experience leading complex clinical studies and/or Local Study Teams in a matrix environment.
• Excellent knowledge of ICH-GCP and relevant local regulatory requirements, with a strong understanding of clinical study management processes in Germany.
• Practical experience in cell therapy studies, such as CAR-T, TCR-T, Treg or comparable cellular therapies, is strongly preferred.
• Experience in clinical study feasibility and in developing recruitment and retention strategies is desirable.
• Proven project, budget, risk and stakeholder management capability.
• Ability to prioritise and deliver high-quality work across multiple activities and conflicting deadlines.
• Excellent written and verbal communication skills in German and English.
• Willingness and ability to travel approximately 60% of working time, primarily within Germany, with occasional international travel and regular overnight stays.
• Valid Class B driving licence.

What You Can Look Forward To:

• An exciting pipeline and innovative cell therapy programmes.
• The opportunity to support advanced therapies from study planning through delivery at clinical trial sites and ultimately for patients.
• Personalised development opportunities with a strong focus on lifelong learning.
• A high level of ownership, trust, appreciation and room to contribute within a focused and passionate team.
• A diverse, inclusive and bias-free work environment committed to the Charta der Vielfalt, where differences are not only welcomed but actively encouraged. We welcome and consider applications from all qualified candidates.
• A sustainable company aiming to become carbon negative across the entire value chain by 2030.
• A comprehensive benefits package, including EGYM Wellpass, corporate benefits and additional local offerings.

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.

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