Global Study Lead

Position Summary

As Global Study Lead (GSL) you will lead the operational delivery of complex global clinical studies from study initiation through archiving. You will work with cross-functional and external partners to set clear study plans, manage risk, and deliver against time, quality and budget goals. We value strategic leaders who are pragmatic, collaborative, and focused on patient-centered outcomes. This role offers strong opportunities for growth, visible impact on clinical development, and the chance to contribute to GSK's mission of uniting science, technology and talent to get ahead of disease together.

Responsibilities

This position within GCSD is accountable for leading the operational strategy, planning and delivery of the oncology study/studies end to end from CSI (Commit to Study Initiation) until study archiving as outlined in the clinical development plan. The GSL owns the vision for study success and prioritization of deliverables.

Key responsibilities include, but are not limited to:
* Accountable for the strategic leadership and delivery of clinical study/studies to time, quality, and budget, company standards and scientific requirements, driving decision-making at pace and strategically leading study team to achieve overall study deliverables.
* Effectively build and lead empowered, high-performing global matrix teams
* Provide Oncology therapeutic area expertise to support operations

* Translate strategic concepts, stakeholder feedback and requirements into cohesive actions for the study team
* Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations

* Ensure appropriate stakeholder communication, including study status, expectations, risks and issues and influence / manage stakeholders at senior director and/or VP level
* Ensure robustness in upfront feasibility and planning
* Accountable for the study budget as well as preparation of materials for governance and /or financial review cycles.
* Oversee quality efforts to ensure protocol compliance and continual inspection readiness for assigned studies.
* Lead assessment, selection, oversight and issue management for FSO vendors
* Optimize utilization of digital and tech tools such as AIML to find efficiencies and more effective ways of working.

Why You?

This is a hybrid role based in GSK HUB locations with an expectation to be in the office 2-3 days per week.

Basic Qualifications:

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Bachelor's degree in life sciences, health science, nursing, pharmacy, or related field.
• Extensive clinical development experience (5+ years) and proven experience in driving operational study delivery to time, cost, and quality within the pharmaceutical industry or CRO environment.
• Significant experience leading complex, global Oncology studies.
• Proven experience working with investigators, external experts, and oversight of Contract Research Organizations and third-party vendors
• Strong knowledge of ICH Good Clinical Practice and global regulatory requirements.
• Proven project and budget management skills with evidence of delivering to timelines and quality targets.
• Proven depth and breadth of experience in clinical delivery, across indications, assets, phases, regions, etc.
• Preferred Qualification
  
  - Postgraduate degree in a life science, clinical research, or project management field.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Inclusion at GSK:

As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.

Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.

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