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Global Study Director, Biopharmaceuticals

2 months ago

Mississauga, Canada AstraZeneca Full time

Global Study Director- BioPharma R&D

Hybrid Work - on average 3 days/week from office

Minimum 1 day from our Mississauga office and 2 days from our Mississauga or Downtown office.

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.

Summary:
Are you ready to play a pivotal role in our BioPharmaceuticals Clinical Operations team and shape the future of clinical research? We are seeking a dynamic Global Study Director (GSD) to provide strategic direction and lead the planning and delivery of high-priority and complex clinical studies that are on the cutting edge of Immunology with a specialized emphasis on Cell Therapy.

Typical Accountabilities:

  1. Provides strategic and operational insight into the design and delivery of global clinical programs, particularly in the development of innovative cell therapies for autoimmune diseases.
  2. Takes accountability for the operational planning, leadership, and delivery of multiple studies or overseeing single, complex/novel studies across assets to ensure they meet set timelines, cost, and quality standards.
  3. Supplies expert clinical operational input into project strategy and study design, and engages in operational interactions with external entities, including regulatory agencies and external collaborators.
  4. Leads, provides guidance, and delegates appropriately to a cross-functional study team to ensure the clinical study progresses as planned, driving achievement of milestones according to timelines, budget, and quality standards.
  5. Facilitates communication across all functions, collaborating with other teams to establish strategies and identify synergies aimed at increasing efficiency of global study teams.
  6. Leads and conducts investigator meetings and other study-related meetings, and contributes to the development of essential study documents in accordance with relevant AZ SOPs.
  7. Helps to shape AstraZeneca’s approach to drug development in the innovative cell therapy field.

Essential Qualifications:

  1. A university degree (or equivalent educational/work experience), preferably in medical or biological sciences or a discipline associated with clinical research.
  2. Experience in cell therapy program development and execution.
  3. Minimum of 7 years progressive experience in clinical research, with at least 5 years of clinical development project management experience (or equivalent).
  4. Extensive knowledge of ICH-GCP, relevant regulatory/ethics requirements, and clinical/drug development, as well as a thorough understanding of cross-functional clinical processes.

Desired Qualifications:

  1. Advanced degree - Masters level education (or higher).
  2. Background in immunology, specifically in autoimmune diseases program development and execution.
  3. Project management certification and proven experience on a global level.
  4. Experience in all phases of a clinical study lifecycle.

If you are ready to take on this exciting challenge and be part of a team dedicated to advancing healthcare through innovative clinical research, we want to hear from you Join us in Mississauga, Canada, and let's shape the future of medicine together.

Great People want to Work with us Find out why:

Are you interested in working at AZ? Apply today

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.

Date Posted: 29-Aug-2024
Closing Date: 12-Sept-2024

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.

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