Provides leadership, oversight and manages the activities of US operational planning and delivery of Phase I clinical trials across all therapy areas (Rx and Vx) to the required quality standards, GSK written standards, US regulations and ICH GCP. As a Phase 1 expert, leads the US team to the successful delivery of Phase 1 studies.

Key Responsibilities:

• Accountable for overseeing the delivery of the US Phase 1 study portfolio and collaborating with the US Leadership team to strategically plan the upcoming Phase 1 study pipeline across all therapeutic areas.

• Responsible for creating, delivering, and maintaining Phase 1 training materials to support the US team in developing and enhancing their Phase 1 competencies.
• Oversee the US team in conducting appropriate site qualifications for Phase 1 units that support our studies.

• Accountable for US delivery of assigned studies to time, budget and quality expectations as defined in the clinical development plan and study protocol as well as in local regulations, IND/GCP/ICH guidelines, GSK Corporate, Vaccines, local SOPS and POLs by leading the local study team consisting of  US clinical operations team members, cross-functional experts, vendor staff and external clinical site staff.
• Demonstrates the ability to effectively manage multiple priorities and responsibilities of increased scope and complexity.
• Ensures that critical US study timelines related to US study activities are accurately forecasted and achieved and that US recruitment targets, patient recruitment cycle times, data and audit quality are met and . provides troubleshooting and problem resolution support for within-country study team to ensure productive, efficient study delivery.
• Accountable for the accuracy of study systems, including completeness of the trial master file, and reporting study delivery progress to study team and key stakeholders.
• Identifies and resolves or escalates issues and risks that may impact study delivery. Takes a leadership role in identifying the root cause of issues, implementing/influencing corrective and preventative actions locally or at a broader study level.
• Provides feedback on performance, capabilities and competencies of study members to line management.
• Available and willing to travel as job requires.

Why you?

Basic Qualifications:

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

• 7+ years of experience in Phase I study management
• Bachelor’s degree in science or arts
• 10+ years’ experience in clinical operations

Preferred Qualifications:

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

• 2+ years’ experience working in a Phase 1 unit
• Masters of Science, PhD or equivalent coupled with previous project management experience.)
• Broad experience in clinical development or equivalent experience in the pharmaceutical or health-related field.
• Excellent matrix leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives
• Effective at problem solving, negotiation and conflict resolution skills in a matrix environment
• Stakeholder management skills required as the role includes interactions with external clinical site staff and senior stakeholders at a central or local level.
• Strong written and verbal communications skills are required in English
• Strong planning and organizational skills, with the ability to work efficiently and effectively in a dynamic environment. Works in an environment that is constantly evolving with new processes and systems, internally and externally and adapts to these changes quickly and efficiently.
• Demonstrates track record in quality decision-making and problem resolution. Able to set and manage priorities, resource and performance targets of local study deliverables. Recognizes potential risks and can implement effective mitigation strategies.
• Recognizes and reacts to changes that impact a study and/or program or practices, and has the skill set to assess the appropriateness of protocol/plans in the local environment.
• Strong project management skills; comfortable projecting, managing, and reporting budget information (business and financial acumen) and able to develop scenarios and effective contingency plans.
• Knowledge or ability to acquire expertise regarding use of multiple systems / tools related to clinical studies.
• Deep knowledge of human research regulations in the US IND/GCP/ICH-guidelines

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