Global Study Director (Cell Therapy)

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Introduction to role

Are you ready to lead the charge in groundbreaking clinical studies? As a Global Study Director (GSD), you will play a pivotal role in the Cell Therapy Clinical Operations organization, driving the operational planning and delivery of high-priority and complex clinical studies. Your expertise will ensure the successful execution of clinical trials, managing quality, timelines, budgets, resources, investigational sites, vendors, and key project deliverables. Leading a cross-functional study team, you will provide direction and guidance to achieve study milestones. Collaborate with internal and external stakeholders to resolve issues and ensure compliance with SOPs, regulatory requirements, and ICH/GCP guidelines. Your leadership will extend to mentoring GSADs and spearheading non-drug programs and improvement projects.

Accountabilities

- Lead and coordinate a cross-functional study team to ensure clinical study progress according to timelines, budget, and quality standards.
- Contribute to vendor/ESP selection activities and lead operational oversight at the study level.
- Assist with operational planning for upcoming clinical studies, interfacing with cross-functional partners.
- Collaborate to establish strategies for increasing efficiency of global study teams.
- Facilitate communication across functions and provide guidance to study team members.
- Serve as the primary AZ contact for outsourced studies, ensuring delivery according to agreed standards.
- Hold accountability for essential study level documents development.
- Ensure external service providers perform to contracted goals and timelines.
- Develop and maintain relevant study plans, including risk management planning.
- Oversee study level performance against plans, milestones, and KPIs.
- Identify and report quality issues within the study and collaborate to overcome barriers.
- Ensure Trial Master File completion and compliance with governance controls.
- Manage study budget through lifecycle and provide progress reports.
- Ensure studies are inspection-ready at all times.
- Support professional development of team members.
- Provide guidance and mentoring to less experienced colleagues.
- Lead non-drug project work and improvement projects.

Essential Skills/Experience

- University degree or equivalent in medical or biological sciences or discipline associated with clinical research.
- Proven project management experience and training.
- At least 7 years of clinical trial experience.
- At least 3 years of experience in global study leadership and team leadership.
- Demonstrated clinical trial expertise in hematology and/or oncology.
- Extensive knowledge of ICH-GCP guidelines and clinical research regulatory requirements.
- Thorough understanding of the cross-functional clinical trial process.
- Strong strategic and critical thinking abilities.
- Proven skills in complex problem solving and decision-making.
- Strong abilities in establishing effective working relationships with senior stakeholders.
- Demonstrated abilities in mentoring.
- Excellent communication and interpersonal skills.
- Ability to manage multiple competing priorities.
- Experience in external provider oversight and management.

Desirable Skills/Experience

- Advanced degree, masters level education or higher.
- Project management certification.
- 5 years of experience in global study leadership and team leadership.
- Significant hematology/oncology expertise.
- Expertise in different phases of clinical delivery.
- Experience with project management software solutions.
- Cell therapy/CAR-T experience.
- Global phase 3 study experience.

Where can I find out more? 

• Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/ 

• Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/ 

• Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en 

• Our US Footprint: Powering Scientific Innovation - YouTube 

AstraZeneca offers an environment where you can be empowered to make bold decisions and move at pace. With a focus on Oncology, we are driven by speed and backed by leadership that empowers every level to prioritize smart risks based on scientific evidence. Our scale, agility, and passion ensure fast delivery every time. Join us in pioneering new frontiers in cancer research, where courage, curiosity, and collaboration drive patient outcomes. Be part of a team committed to improving the lives of millions with cancer.

Ready to take on this exciting challenge? Apply now to join our dynamic team!

Annual base salary for this position ranges from $171,622.4 to $ 257,433.6 USD. AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs.  In some cases, offers outside the range may also be considered to address unique circumstances.

In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role).  Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com. 

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