Global Study Director (GSD) at AstraZeneca

Gaithersburg, Maryland, United States -

Full Time

Start Date

Immediate

Expiry Date

21 Mar, 26

Salary

230208.0

Posted On

21 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Project Management, Clinical Trials, Leadership, Hematology, Oncology, ICH-GCP Guidelines, Problem Solving, Communication, Interpersonal Skills, Vendor Management, Risk Management, Team Mentoring, Strategic Thinking, Budget Management, Collaboration, Quality Assurance

Industry

Pharmaceutical Manufacturing

Description

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects. Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention. 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! The annual base pay (or hourly rate of compensation) for this position ranges from $153,472 to $230208. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. 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. #LI-Hybrid Date Posted 16-Dec-2025 Closing Date 08-Jan-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

Responsibilities

The Global Study Director will lead and coordinate a cross-functional study team to ensure clinical study progress according to timelines, budget, and quality standards. They will also serve as the primary contact for outsourced studies and manage essential study documents and performance metrics.