Global Clinical Operations Program Director

at  AstraZeneca

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 and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.
Join us in our mission to eliminate cancer as a cause of death. As a Global Clinical Operations Program Director (GPD) in our Oncology R&D department, you will play a pivotal role in the development and delivery of our clinical operations. This role offers a broad scope of responsibilities, supporting one or several products in Phase 3 development or on the market. You will provide strategic operational leadership and oversight of a suite of global clinical studies within a program, ensuring new innovative design and delivery models are used appropriately.

ACCOUNTABILITIES:

As a GPD, you will lead cross-functional teams in the planning and delivery of a defined clinical program of studies. You will provide clinical operations expertise into the project, using new innovative design and delivery models to support governance interactions and project start-up. You will also be responsible for managing clinical plans in business reporting systems, leading large or complex deliverables, and providing project leadership to cross-functional Clinical Submission Teams

Essential Skills/Experience:

• University degree (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 organizations.
• Proven knowledge of project management tools and processes
• Proven experience in 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
• Proven leadership promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives
• Skilled & experienced in change management
• Ability to look for and champion more efficient and effective methods/processes of delivering clinical operations components focusing on key performance metrics around reliability, productivity, cost, and quality
• Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills with ability to work effectively with others at all levels of the organization
• Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a regional and local environment
• Integrity and high ethical standards
• Excellent stakeholder management skills
• Adaptability

DESIRABLE SKILLS/EXPERIENCE:

• Project management certification is desirable but not mandatory.
• Knowledge of process improvement methodology such as Lean Sigma/Change Management is desirable but not mandatory
• Regulatory submission experience
• Proven knowledge of clinical operations,
• Experience with development and implementation of digital health initiatives in Clinical Studies

Please refer the Job description for details