Local Study Associate Director, Cell Therapy
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Job Description
Field-based Local Study Associate Director leading German cell therapy clinical studies for AstraZeneca’s oncology R&D. Overseeing sites, monitoring, recruitment, budgets and regulatory delivery.
Responsibilities:
- Lead Local Study Teams consisting of CRAs and CSAs, coordinate activities and optimise team performance
- Hold overall responsibility for country study commitments and timely delivery of data to required quality, budget and timelines
- Provide end-to-end oversight of site identification, qualification, activation, initiation, management and close-out
- Conduct site qualification, initiation, routine monitoring, for-cause and close-out visits as required
- Maintain regular on-site presence at certified cell therapy centres
- Work closely with investigators, study coordinators and site personnel
- Identify clinical and operational risks, agree mitigation actions and follow them through to resolution
- Lead or contribute to country and site feasibility activities
- Provide input to study design, site selection, allocation and recruitment forecasts
- Develop country-specific and site-specific recruitment and retention strategies
- Ensure timely submission of 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
- Support audit, inspection and final archiving activities
- Keep local and global stakeholders informed of progress, milestones, risks and delivery challenges
- Collaborate with international project teams, Medical Affairs, Site Partnerships and other internal functions
Requirements:
- Bachelor's degree in life sciences, medicine or a comparable field
- 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
- 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 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
- Advanced scientific degree is advantageous
Benefits:
- 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
- Sustainable company aiming to become carbon negative across the entire value chain by 2030
- Comprehensive benefits package, including EGYM Wellpass, corporate benefits and additional local offerings
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