Global Clinical Operations Program Director - Haematology

ABOUT ASTRAZENECA

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation 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.

ONCOLOGY RESEARCH & DEVELOPMENT

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 an exciting oncology portfolio 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 in Haematology 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.

Haematology 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. Supportive team players, we draw on diverse knowledge from across the business and external partners to come to bear on the toughest medical challenges.

What you’ll do

The Senior Global Clinical Operations Program Director (Sr GPD) is a core global role within the Haematology R&D Clinical Operations and is accountable to the Global Product Team (GPT) for the operational delivery of the agreed clinical development plan and is one of three core members of the Clinical Program Team (CPT), a strategic and operational leadership team whose remit is to maximize the scientific and clinical relevance and value of Haematology led projects. The CPT delivers the Target Product Profile directed strategy and clinical benefit/risk assessment to time, cost and quality to the GPT or equivalent teams.

The Sr GPD is 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. The role involves integrating strategy, design, feasibility line management and operational planning to produce business-focused clinical drug development programs that align with AstraZeneca priorities and strategy. The Sr GPD brings product knowledge and strategic thinking to support governance interactions, leads the delivery of a program of studies and is accountable for the delivery of the clinical support of regulatory marketing applications and post registration product maintenance deliverables.

• Accountable for oversight of all clinical operations activities within the program (Early and Late development), ensuring relevant issues are escalated to GPT (or equivalent team) and for ensuring provision of clinical operations expertise/input into the program (e.g. feasibility, country selection, operational input into design, risk and external partner management) using new innovative design and delivery models to support governance interactions and project start-up.
• Plans, directs and delivers the operational components of assigned clinical programs from design concept to final CSR, through to study closed and archived within agreed budget, time, quality and aligned KPIs
• Responsible for providing strategic and operational input to cross-functional program development plans, data interpretation and accountable for cross-functional leadership roles as delegated from the Global Project Team, e.g., leadership of cross functional product development team activities. Provide expert clinical operational input into: Target Product Profile (TPP), Clinical Development Plan (CDP), Study Synopsis, Clinical Study Protocol, Clinical Study Report, IB, briefing documents, etc., to ensure seamless delivery of programs through effective collaboration.
• Engagement with preclinical and translational science as well as statistics and regulatory in order to design and deliver robust clinical development plans.
• Effectively partner with the Global Clinical Head (GCH), Global Clinical Lead (GCL), and the Biometrics Team Leader to provide leadership, clear direction and aligned goals to the CPT members/clinical delivery teams
• As a member of the CPT, responsible for efficient and effective program management of all GPT (or equivalent team) clinical development deliverables, including strategy, design and delivery of clinical program/studies to scope, quality, budget, time; managing resource and risk.
• Accountable for establishing team structure and ways of working to ensure CPT is a high performing team.
• The Sr GPD is accountable for the line management of Clinical operational leaders at the Global Study level (Global Study Associate Directors, GSAD or Global Study Directors, GSD) and program level (Global Program Director GPD) associated within the aligned GPT deliverables.
• Accountable for the delivery of the clinical component deliverables of regulatory submissions, providing support for regulatory interactions and reports and clinical contributions to inspection readiness.
• Acts 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
• Accountable for ensuring timely compliance with companywide governance controls (e.g. financial oversight, planning and control, continuous assurance, Clinical Trial Disclosure). Accountable for manage clinical plans (cost, FTEs and timelines) in business reporting systems, such as PLANIT

Essential for the role

• Bachelor of Science/Master of Science degree in related discipline, or equivalent work experience. Advanced degree is preferred
• Experience in Phase 1 dose escalation and/or registrational Phase 3 trials
• 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

Desirable for the role

• Higher degree e.g. PhD, MD, PharmD
• 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
• Line Management experience

This role can sit at our Cambridge, UK; Mississauga, Canada; Gaithersburg, Maryland or Waltham, MA: site’s

Why AstraZeneca?

Here you’ll have the opportunity to make a meaningful difference to patients’ lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines – for the world’s most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and shaping the patient ecosystem.

So, what’s next?

Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

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Competitive Salary and Benefits