Head of IRT [RTSM]

Site Name: USA - Pennsylvania - Philadelphia, UK - Hertfordshire - Stevenage, UK - London - Brentford
Posted Date: Aug

Reporting to the Director, Core Technologies, the Director, Head of IRT provides will provide functional leadership, oversight, and strategic direction for all IRT activities. This role will provide thought leadership and partner with Senior leadership in the business, IT & clinical operations.

This position is primarily responsible for oversight of global team, leading the development of IRT system to meet the needs of portfolio and business. The role requires a combination of deep business skills and technical expertise to in product development and system support. The leader in this role is expected to maintain an awareness of industry benchmarks and evaluate innovative new technologies to ensure IRT processes are at the 'best practice' level of performance. The position is best suited for someone with growth mindset and the ability to drive change and innovation that supports GSK ambition for a modernized and digital clinical supply chain.

Key Responsibilities:

• Lead the IRT Operations team of 12-15 FTE's, with accountability for overall delivery demonstrating leadership essentials
• Responsible for directing and managing the use of IRT and technology to support GSK studies
• Partner with the Senior Leadership to deliver future-state capabilities which lead to robust, scalable solutions to support clinical trial supply activities
• Responsible for oversight, strategic direction and implementation of IRT systems-related projects, ensuring project milestones and system requirements are met
• Collaborates with supply chain function SMEs in the development of processes and integrations that support simplification and achieve acceleration of portfolio
• Be a change advocate, leading transformational tasks which focus on simplification of processes and system design, and with holistic approach in ensuring interoperability amongst clinical & supply chain ecosystem.
• Contributes to the development of GSK clinical supply chain digital strategy and technology roadmaps in close collaboration with business and IT partners
• Initiates continuous improvement efforts, identifies and develops best practices, and enforces standardization when appropriate throughout the system implementation lifecycle
• Works well with senior leadership with ability to effectively communicate and influence outcomes achieving GSK objectives
• Builds and develops talent with focus on inclusion and diversity
• Drive functional improvements, challenge the status quo and be responsible for identifying and delivering innovative approaches to improve processes
• Act within an inspection-ready and quality mindset across all activities and represent as needed during internal and external audits, ensuring IRT processes and documentation are fit for purpose and remain in compliance with all appropriate regulatory requirements (cGXP, 21 CFR Part 11)
• Manage IRT vendor relationships and seek to utilize the best IRT vendors in the industry
• Explore uses of emerging technology to enhance clinical supply efficiency
• Support and provide insights on GSK's modernization journey and digital supply chain initiatives

Why you? Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• 12+ year operational experience in clinical trials
• Previous supervisory and line management experience
• Project management and/or continuous improvement experience
• Demonstrated knowledge of clinical development processes, global clinical operations, IRT systems and processes
• Knowledge and experience working in a GMP / GCP environment and with regulatory audit teams
• High focus on data integrity principles in collecting/updating data collected via IRT system

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• MBA or master's degree in supply chain management
• Basic understanding of statistical principles (randomization method, blinding/unblinding, potential bias, adaptive design, etc)
• Knowledge of Help Desk support activities

Why GSK?

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and geneticsscience; and a new world-leading consumer healthcare company of loved and trusted brands.

With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas a new GSK where outstanding people thrive.

Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culturethat is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership ofgoals and support to succeed; and where we do the right thing . So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge to get Ahead Together.

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