Senior Global Clinical Operations Program Director - Late Oncology
Location: Cambridgeshire, Gaithersburg, Maryland, Waltham, Massachusetts
Job Type: Full time
Job Profile: Senior Global Clinical Operations Program Director
Location: Onsite with Flexibility in Gaithersburg MD, Waltham MA, Mississauga Canada, Cambridge UK OR Warsaw Poland
Do you have expertise in and a passion for Global Clinical Program Management? Would you like to apply your expertise to impact the development of late oncology clinical development in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.
Join a dedicated Oncology team that’s growing fast and building a strong track record of success. We have multiple indications and many high-quality molecules at all stages of development – but we see even more potential. Oncology is driven by speed. We make bold moves at the cutting edge. Transforming molecules to change the practice of medicine. Here it’s our scale, agility and passion that makes sure we deliver fast, every time.
Late Development Oncology sits within our broader Oncology Research & Development organization. We take an inter-disciplinary approach including novel biomarkers, AI, novel endpoints and cutting-edge trial designs to shape the future of our business and Oncology. 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.
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.
What you’ll do:
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 strategic 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. You will:
- Effectively partner with the Global Clinical Leader and Global Project Statistician to provide clear direction and aligned 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 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.
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 of Oncology assets.
Comprehensive knowledge of clinical operations and the clinical and pharmaceutical drug development process (in the Oncology Therapeutic Area is preferred).
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 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
AstraZeneca an Employer of Choice:
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! If you have what it takes to create a culture of courageous leadership, creativity and collaboration, please apply today!
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
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 authorization and employment eligibility verification requirements.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.