Job Description

Location: This role can sit at our Mississauga or Barcelona site (Hybrid 3 days/week in office)

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation \xe2\x80\x93 ultimately providing employees with the opportunity to work across teams, functions and even the globe.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we\xe2\x80\x99re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

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\xe2\x80\x99s 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\xe2\x80\x99ll 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.

Additionally, the Sr GPD may lead or contribute to improvement and change projects within clinical operations and/or other business areas, as well as line potential management of clinical operations personnel.

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

AstraZeneca decision maker and escalation point with external partners and vendors for clinical delivery.

Responsible for leadership and program management of non-drug project work as assigned, eg cross functional improvement initiatives

Contribute to functional and cross functional initiatives as Subject Matter Experts

Mentor, coach, and support people development within Clinical Operations and other functions as appropriate. Potential line management oversight as required.

Actively participate in networking both within and outside the therapeutic area, sharing best practises and lesson learnt

Be early adopters for new ways of working and act as ambassadors for change, driving the implementation and utilization of new initiatives.

Essential for the role

Bachelor of Science/Master of Science degree in related discipline, or equivalent work experience. Advanced degree is preferred

At least 10 years global drug development experience within clinical function

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

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 Oncology experience required; Haemtology experience preferred

Experience of early and late phase clinical delivery

At least 10 years global drug development experience within clinical function

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

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AstraZeneca is committed to taking every reasonable precaution to protect employees, our customers and the healthcare systems in the communities in which we serve. In an effort to protect the wellbeing of our employees and customers, full COVID-19 vaccination is an essential requirement of all positions at AstraZeneca. As such, all offers of employment will be conditional upon either (i) proof of full COVID-19 vaccination or (ii) proof of need for accommodation under relevant human rights legislation, and AstraZeneca\xe2\x80\x99s determination that the requested accommodation can be provided without undue hardship. You will be required to submit proof of full vaccination or proof of need for accommodation during our background screening process.

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing .

Date Posted 30-May-2023

Closing Date 11-Jun-2023

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.

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