Senior Global Clinical Operations Program Director
hace 3 meses
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 - 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’re 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’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.
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
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