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Global Operations Program Director

Global Operations Program Director

AstraZenecaGaithersburg, MD, US
9 days ago
Job type
  • Full-time
Job description

Global Clinical Operations Program Director (GPD)

Are you ready to lead the charge in transforming clinical operations within Late Stage R&D? As a Global Clinical Operations Program Director (GPD), you will play a pivotal role in leading all aspects of global clinical studies, ensuring they meet scope, quality, budget, and time requirements. Your expertise will drive innovative design and delivery models, aligning clinical drug development programs with strategic priorities. You will lead cross-functional teams, contribute to regulatory submissions, and spearhead improvement projects. This is your chance to make a significant impact on the future of medicine!

Accountabilities :

  • Lead cross-functional teams in planning and delivering clinical programs to scope, quality, budget, and time.
  • Provide strategic oversight for global study leaders on behalf of Sr GPD and Clinical Program Team (CPT).
  • Offer clinical operations expertise into project design, feasibility, and risk management using innovative models.
  • Develop new case opportunities for governance review.
  • Lead Clinical Submission Teams for marketing applications and regulatory interactions.
  • Drive large or complex deliverables, solving operational issues and ensuring delivery through partners.
  • Manage clinical plans in business reporting systems like PLANIT.
  • Act as AZ point of escalation for study teams with external partners.
  • Lead non-drug project work and cross-functional improvement initiatives.
  • Mentor and support staff development.
  • Participate in networking and exchange guidelines within and outside therapeutic areas.
  • Support new ways of working and motivate change initiatives.

Essential Skills / Experience :

  • BS or equivalent, preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred.
  • At least 10 years' experience from within the pharmaceutical industry or similar large multinational organization.
  • Proven knowledge of project management tools and processes.
  • Proven experience of clinical development / drug development process in various phases of development and therapy areas.
  • Proven ability to learn by working in multiple phases, TAs and / or different development situations.
  • Experience from leading clinical projects and deliverables or similar expertise from other areas of drug development (such as pharmaceutical development).
  • Ability to mentor, develop and educate staff.
  • Desirable Skills / Experience :

  • Project management certification.
  • Knowledge of process improvement methodology such as Lean Sigma / Change Management.
  • Regulatory submission experience.
  • Proven knowledge of clinical operations.
  • Experience with development and implementation of digital health initiatives in Clinical Studies.
  • When we put unexpected teams in the same room, we spark bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

    At AstraZeneca, we are driven by a shared ambition to eliminate cancer as a cause of death. Our team is dedicated to pioneering new frontiers in Oncology, fusing cutting-edge science with the latest technology to achieve breakthroughs. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we are committed to delivering six new molecular entities by 2025. Our collaborative research environment unites academia and industry, expediting research in some of the hardest-to-treat cancers. Join us to build a rewarding career while improving the lives of millions with cancer.

    Ready to make bold decisions and lead at every level? Apply now to join our team!

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    Program Director • Gaithersburg, MD, US

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