Sr. Global Clinical Operations Program Director (Respiratory and Immunology)

The Senior Global Clinical Operations Program Director (Sr GPD) is a pivotal global role within the Clinical Operations function of Late Stage R&D (BioPharmaceuticals and Oncology). This role is accountable to the Global Product Team (GPT) for delivering the agreed clinical development plan and is one of three core members of the Clinical Program Team (CPT). The Sr GPD brings product knowledge and critical thinking and leads the delivery of a program of studies.

Accountabilities

• Accountable for oversight of all clinical program activities, ensuring relevant issues within a program are escalated to GPT and for ensuring provision of clinical operations expertise/input into the program.
• Effectively partner with the Global Clinical Head (GCH) and the Biometrics Team Leader to provide leadership, clear direction, and aligned goals to clinical delivery teams.
• As a member of the CPT, responsible for efficient and effective program management of all GPT clinical development deliverables, including strategy, design, and delivery of clinical program/studies to scope, quality, budget, time; managing resource and risk.
• Accountable for establishing a high-performing team.
• Accountable for the project management of the clinical component results of regulatory submissions.
• Ensure alignment of the clinical strategy, transfer of product knowledge, and champion products that are between early and late-stage organizations.
• Accountable for ensuring timely compliance with companywide governance controls and handling clinical plans (cost, FTEs, and timelines) in business reporting systems, such as PLANIT.
• AstraZeneca decision maker and escalation point with external partners.
• Contribute to functional and cross-functional initiatives as Subject Matter Experts.
• Mentor, coach, and support people development within Clinical Operations.
• Actively participate in networking both within and outside the therapeutic area, sharing best practices and lessons learned.
• Be early adopters for new ways of working and act as ambassadors for change.

Essential Skills/Experience

• Bachelor of Science/Master of Science in related discipline (advanced degree is preferred).
• Extensive global drug development leadership.
• Extensive experience across the product life cycle with experience in late-stage development and ideally across multiple therapeutic areas.
• Clinical operations knowledge with strong track record of program delivery.
• Extensive knowledge of the clinical and pharmaceutical drug development process.
• Significant experience of program management and use of project management techniques in complex projects, including resourcing, financial management, and business case development.
• Strong strategic influencing skills; ability to influence broadly within and outside the organization.
• Excellent written and verbal communication skills.
• Track record of planning, prioritization, and delivery success.
• Willingness to travel both domestic and international.

Desirable Skills/Experience

• Demonstrated ability to drive process improvement and/or functional work.
• Regulatory submission experience.
• Previous success in working in Japan and China to ensure delivery of global programs.
• Proven experience in leading teams through change.

When we put unexpected teams in the same room, we ignite 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. Join us at AstraZeneca where we follow the science to explore new possibilities. We are committed to making a difference by treating, preventing, modifying, or even curing some of the world’s most complex diseases. Our passion for science drives us to fuse data and technology with scientific innovations to achieve groundbreaking breakthroughs. Here you will find an inclusive environment where curiosity thrives, collaboration is key, and diverse perspectives are valued. We offer numerous opportunities for growth and development as we push the boundaries of science to deliver life-changing medicines. Ready to make an impact? Apply now!