V&i Head Study Management

1 month ago

Mississauga, Canada AstraZeneca Full time

**V&I Head Study Management**

**Location: Gothenburg, SE; Mississauga, CA or Warsaw, PL**

**Competitive salary and benefits**

**Make a more meaningful impact to patients’ lives around the globe**

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.

You will be responsible for the delivery of all internally and externally delivered studies within the Therapeutic Area of responsibility, to time, quality & cost. You will ensure operational excellence within clinical studies and that all clinical trials will comply with GXPs. You’ll be responsible for partnering with cross-functional leaders across Biophama Clinical Operations and V&I TA as well as external vendors to provide input into and translate the V&I strategy into a Study Management operational plan spanning early and late development programs. This will include, but is not limited to, capabilities, ways of working and resources for optimal delivery of existing and future AZ portfolio. You will ensure operational input is provided into timelines, budget and study design to inform the therapeutic area strategy. You will also be responsible for the line management and development of the teams.

Typical accountabilities:

- Accountability for the delivery of clinical studies to industry leading quality, timelines and cost
- Accountable for delivering the operational aspects of the internal and external portfolio in the given TA
- Effectively engage and collaborate with clinical operations and other TA stakeholders to ensure alignment to strategies and priorities. Ensure any performance risks and issues are identified and effectively managed.
- Effectively engage and collaborate with the Heads of Study Management for other TAs to anticipate and plan for capacity planning, resource management and talent management
- Management of resources (budgets and headcount) across assigned teams
- Line management of the Study Management department delivering performance management and guiding the professional development of all direct reports
- Designs or manages the implementation of the Study Management strategy and feasibility study within Clinical Operations both regionally and globally
- Uses expertise and knowledge of global issues to develop strategic Study Management objectives for inclusion into AstraZeneca’s annual business objectives
- Defines strategies or leads AstraZeneca’s response to complex technical issues for specific medical aspects in relation to current projects, new projects and various study delivery.
- Provides expert advice in the area of specialism, influencing the development of KPIs to the global business and Global Clinical Development
- Maintains a high degree of understanding and awareness on new Study Management trends and developments
- Contributes to or manages the development of the senior management team in area of expertise
- Drives innovative approaches to study management delivery, and leadership (sponsorship) of continuous improvement projects.

**Essential criteria**:

- University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research
- At least10 years’ experience within pharmaceutical industry or similar biotech global industry
- Proven global experience of clinical development/drug development process across various phases
- Experience leading clinical studies
- Proven leadership skills, ability to set and lead priorities
- Ability to motivate and empower others
- >10 years’ extensive experience in Development and Patient Safety
- Ability to effectively communicate with stakeholders within AstraZeneca
- Leadership expertise?
- Experience working with Senior-level stakeholders
- Strong strategic influencing and interpersonal skills
- Extensive networking skills, ability to interact widely and effectively both internally and externally

**Desirable criteria**:

- Line management experience
- Expert reputation within the business and industry
- Extensive knowledge of the latest technical and regulatory expectations
- Experience in development and implementation of digital health and patient centric strategies into clinical studies

**Why AstraZeneca?**

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

**So, what’s next?**

This role will close on the 9th February 2023.

**Where can I find out more?

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