Senior Global Clinical Operations Program Director

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.

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.

 The Sr GPD is responsible for program leadership and management of all clinical operations deliverables to scope, quality, budget, time, resource and risk, ensuring new innovative design and delivery models are used appropriately. The role involves integrating strategy, design, feasibility, line management and operational planning to produce business-focused clinical drug development programs that align with AstraZeneca priorities and strategy

Typical Accountabilities

• Accountable for oversight of all clinical program activities, ensuring relevant issues are brought up to GPT (or equivalent team) and for ensuring provision of clinical operations expertise/input into the program (e.g. feasibility, country selection, operational input into design, risk and external partner management) using new innovative design and delivery models to support governance interactions and project start-up.
• Effectively partner with the Global Clinical Head (GCH) and the Biometrics Team Leader to provide leadership, clear direction and shared goals to the CPT members/clinical delivery teams
• As a member of the CPT, responsible for efficient and effective program management of all GPT (or equivalent team) clinical development deliverables, including strategy, design and delivery of clinical program/studies to scope, quality, budget, time; managing resource and risk.
• Accountable for establishing team structure and ways of working to ensure CPT is a high performing team.
• The Sr GPD is accountable for line management of Clinical operational leaders at the Global Study level (Global Study Associate Directors, GSAD or Global Study Directors, GSD) and program level (Global Program Director GPD) associated within the aligned GPT objectives.
• Accountable for the clinical operations component deliverables of regulatory submissions, providing support for regulatory interactions and reports and clinical contributions to inspection readiness.
• Acts as the initial and program-level AZ operational collaborate with externally managed/outsourced partners (e.g. CRO/ARO) and collaboration/alliance partners for program planning and delivery
• Accountable for ensuring timely compliance with companywide governance controls (e.g. financial oversight, planning and control, continuous assurance, Clinical Trial Disclosure). Accountable for manage clinical plans (cost, FTEs and timelines) in business reporting systems, such as PLANIT
• AstraZeneca decision maker and critical issue point with external partners and vendors for clinical delivery.
• Responsible for leadership and program management of non-drug project work as assigned, e.g. cross functional improvement initiatives
• Contribute to functional and cross functional initiatives as Subject Matter Experts
• Mentor, coach and support people development within Clinical Operations and other functions as appropriate
• Actively participate in networking both within and outside the therapeutic area, sharing best practises and lesson learnt
• Be early adopters for new ways of working and act as ambassadors for change, driving the implementation and utilization of new initiatives.
  

Education, Qualifications, Skills and Experience

Essential

• Bachelor of Science/Master of Science degree in related subject area, or equivalent work experience. 
• Extensive global drug development leadership or equivalent leadership experience demonstrated in a variety of roles. 
• Extensive experience across the product life cycle with experience in Cell Therapy development and ideally across multiple therapeutic areas
• Clinical operations knowledge with strong track record of delivery
• Expert level knowledge of the clinical and pharmaceutical drug development process
• Proven track record to develop programs to meet business goals and to assess business risk versus potential value; ability to understand global business requirements
• Significant experience of program management and use of project management techniques in sophisticated projects, including resourcing, financial management and business case development
• Travel both domestic and international

Great People want to Work with us! Find out why:

• GTAA Top Employer Award for 10 years
• Top 100 Employers Award
• Canada’s Most Admired Corporate Culture
• Learn more about working with us in Canada
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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 and may be requested by emailing AZCHumanResources@astrazeneca.com.

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. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.