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The Senior Global Clinical Operations Program Director (Sr GPD) is a core global role within the Clinical Operations function of Late Stage R&D (BioPharmaceuticals and Oncology) and is accountable to the Global Product Team (GPT) for the 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 which remit is to maximize the scientific and clinical relevance and value of late stage 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 program 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 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 project management 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.
- Accountable for oversight of all clinical program activities, ensuring relevant issues within a program are called out 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.
- Effectively partner with the Global Clinical Head (GCH) and the Biometrics Team Leader to provide leadership, clear direction and aligned goals to 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 hard-working team.
- Accountable for the project management of the clinical component deliverables of regulatory submissions, providing support for regulatory interactions and reports and clinical contributions to inspection readiness.
- Ensure alignment of the clinical strategy, transfer of product knowledge and champion products that are between early and late stage organizations.
- 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 point of contact 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
- Bachelor of Science/Master of Science degree in related subject area, or equivalent work experience. Advanced degree is preferred
- 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
- 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
So, what’s next?
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Advertising opens on 8th March 2022 and we welcome with your application; CV and cover letter, no later than 22nd March 2022