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Senior Global Clinical Operations Program Director, Late Development Oncology

4 months ago


Waltham, United States AstraZeneca Full time

At AstraZeneca, we push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. We are a science-based, leading and decisive Oncology enterprise united in our vision to eliminate cancer as a cause of death. With one of the broadest and deepest Oncology pipelines in the industry, there are many opportunities to work with new and novel drugs and help discover what's next. We foster a mindset of courage, where everyone is empowered to step up, innovate and work at pace. We lead through true collaboration, building collective wisdom by giving everyone a chance to input. It's science with an impact-making a difference for patients and people around the world.

Are you ready to make a difference? Apply now and join us in our mission to eliminate cancer as a cause of death

Introduction to role:

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.

Accountabilities:

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.

Essential Skills/Experience:

Bachelor of Science/Master of Science degree in related discipline, or equivalent work experience. Advanced degree is preferred 12 years of relevant 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 late stage development and ideally across multiple therapeutic areas Clinical operations knowledge with strong track record of delivery Comprehensive knowledge of the clinical and pharmaceutical drug development process Proven ability 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 complex projects, including resourcing, financial management and business case development Proven ability to develop successful collaborations with internal stakeholders and external partners Strong strategic influencing skills: ability to influence broadly within and outside the organisation Excellent written and verbal communication skills Proven teamwork and ability to work collaboratively across a wide range of disciplines Track record of planning, prioritisation and delivery success Willingness to travel both domestic and international

Desirable Skills/Experience:

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 programmes 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 Experience in line management of leadership roles

Date Posted

22-May-2024

Closing Date

06-Jun-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.