Job Title: Senior Global Clinical Operations Program Director, Late Development Oncology
Locations Available: Gaithersburg MD US, Cambridge UK, Toronto Canada, Warsaw Poland
The Senior Global Clinical Operations Program Director - Late Oncology is a core global role within the Clinical Operations function of Late Stage R&D (BioPharmaceuticals and Oncology), focusing on operational strategy and delivery. The span of the responsibilities is broad and may support one or several products depending on their size and complexity. The products supported will be Phase 3 development or on the Market, but the program may include studies in all phases of drug development.
The Senior Global Clinical Operations Program Director - Late Oncology sits within Clinical Operations of Late Stage Oncology R&D and is accountable for leading the Clinical Program Team (CPT), a strategic and operational leadership team. You will be responsible for program leadership of all Late Stage clinical development deliverables (scope, quality, budget, time, resource and risk). The role involves integrating strategy, design, feasibility and operational planning to produce business-focused clinical drug development programs that align with AstraZeneca priorities and strategy. The DCD brings product knowledge and critical thinking to support governance interactions, lead the delivery of a program of studies and co-ordinate the delivery of the clinical components of Health Authority submissions and documents.
What you will do:
Essential Education, Skills and Experience Required:
- Effectively partner with the Global Clinical Leader and Global Project Statistician to provide clear direction and agreed on 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 deliverables 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 lead who collaborates with our externally managed/outsourced partners (e.g. CRO/ARO) and collaboration/alliance partners for program planning and delivery
- Does all of this sound intriguing to you? If so, we are eager to hear from you!
Preferred Education, Skills and Experience for this role are:
- Bachelor of Science or equivalent degree
- Extensive global drug development leadership or equivalent leadership experience demonstrated in a variety of roles.
- Extensive 10-15 years experience across the product life cycle with experience in late stage development.
- Comprehensive knowledge of clinical operations and the clinical and pharmaceutical drug development process.
- Proven 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 case justification development.
- Willingness to travel both domestic and international.
Employer of Choice
- 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
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 offer a competitive Total Reward program including a market driven base salary, bonus and long term incentive. We also provide a generous paid time off program and a comprehensive benefits package!
AstraZeneca aligns with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
To safeguard the health and wellbeing of our employees, customers and communities, AstraZeneca is mandating COVID-19 vaccination for all US-based AstraZeneca and Alexion employees. We will provide accommodations for those unable to be vaccinated based on applicable law, such as those who cannot get vaccinated due to a medical or religious reason. We continue to work diligently to ensure the health and safety of our employees and workplaces and have in place a number of safety measures and guidelines, including providing access to personal protective equipment and COVID-19 testing.
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