Senior Global Clinical Operations Program Director

Job Profile: Senior Global Clinical Operations Program Director

Location: Mississauga, ON (hybrid 3 days/week in office). Flexibility in Waltham MA or Gaithersburg MD

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.

Join us as a Senior Global Clinical Operations Program Director (Sr GPD) in our Oncology R&D department. This core global role within the Clinical Operations function of Late Stage R&D is accountable to the Global Product Team (GPT) for the operational delivery of the agreed clinical development plan. As a Sr GPD, you will be 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.

What you’ll do:

As a Sr GPD, you will be accountable for oversight of all clinical program activities, ensuring relevant issues are escalated to GPT. You will partner effectively with the Global Clinical Head (GCH) and the Biometrics Team Leader to provide leadership, clear direction and aligned goals to the CPT members/clinical delivery teams. You will also be responsible for establishing team structure and ways of working to ensure CPT is a high performing team. Additionally, you will be accountable for the clinical operations component deliverables of regulatory submissions, providing support for regulatory interactions and reports and clinical contributions to inspection readiness. You will:

• Effectively partner with the Global Clinical Leader and Global Project Statistician to provide clear direction and shared goals
• Drive and implement critical initiatives on the program level ensuring the CPT is operating as a high functioning team
• Deliver efficient and effective program management of all GPT clinical development results including project strategy, design and delivery of program/studies to time, on budget and with quality
• Oversee clinical components of regulatory and related submissions, maintenance support for regulatory interactions and reports, and clinical contributions to inspection readiness.
• Lead all clinical operations activities within the program and for ensuring provision of clinical operations expertise/input into the program (e.g. feasibility, country selection, operational input into design, Risk based Quality Management and external partner management)
• Act as the initial and program-level AZ operational interface with externally managed/outsourced partners (e.g. CRO/ARO) and collaboration/alliance partners for program planning and delivery

Essential for the role

• Bachelor of Science or equivalent degree.
• 12+ years progressive global drug development leadership or equivalent leadership experience demonstrated in a variety of roles.
• 12+ years eExtensive experience across the product life cycle with experience in late stage development of Oncology assets.
• Extensive knowledge of clinical operations and the clinical and pharmaceutical drug development process (in the Oncology Therapeutic Area is preferred).
• Validated ability to develop programs to meet business goals and to assess business risk versus potential value.
• Significant experience of program management and use of project management techniques in complex project including resourcing, financial management and business case development.
• Willingness to travel both domestic and international.

Desirable for the role

• Master of Science / Advanced degree preferred
• Demonstrated ability to drive process improvement and/or functional work
• Experience of implementing changes in ways of working that focus on increasing efficiency
• Regulatory submission experience
• Previous success of working in Japan and China to ensure delivery of global programs to meet business needs
• Proven experience in leading teams through change
• Experience of and insight into the Clinical environment to be able to drive major improvement programs

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

• GTAA Top Employer Award for 9 years
• Learn about our culture
• Learn more about working with us in Canada
• View our YouTube channel

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.