Director, Clinical Operations Asset Lead

Business Introduction

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success.

We’re uniting science, technology, and talent to get ahead of disease together.

The Clinical Operations Asset Lead is the single point of accountability for clinical operations delivery across the full asset lifecycle. Representing Global Clinical Operations at the asset level, the COAL sets and delivers the program level operational strategy that enables execution of the scientific vision.

Working in close partnership with clinical, biostatistics, and functional experts, the COAL drives informed decision making, provides strategic leadership to Study Delivery Teams, and ensures high quality, ontime delivery-while retaining full accountability for overall asset outcomes.

This COAL may take on responsibilities across both early and late phase, depending upon demand in our RIIRU portfolio.

• Contribute to the Clinical Development Plan (CDP) and Integrated Evidence Plan (IEP) across Research, Development, and LCM
• Ensure study designs are operationally feasible, regionally compliant, cost effective, and deliver high quality data
• Provide protocol level operational input and support amendments through governance review

• Lead and own the assetlevel resourcing strategy (inhouse vs outsourced)
• Approve vendor selection, contracting, and oversight in line with GSK standards

• Serve as escalation point for critical operational, quality, and GCP issues
• Lead cross functional coordination to ensure inspection readiness and high quality study delivery
• Ensure transparent communication of risks, issues, and successes across GCO

• Own assetlevel delivery plans, scenario modeling, and budget forecasts
• Drive innovative, patientcentric and efficient approaches to study execution
• Represent Clinical Operations at governance boards and support clinical filing activities

• Own the assetlevel risk register and mitigation strategy using Quality by Design
• Ensure accurate, current operational data in GSK systems until transition to study teams
• Lead internal and external stakeholder engagement across the asset

• Demonstrates conceptual, analytical and strategic thinking to innovative approaches to clinical delivery, leverage external technology and networks and build internal capability
• Ability to translate strategic concepts, scientific requirements, stakeholder feedback and expectations into cohesive actions for the Asset team
• Innovative and change adept whilst identifying and embracing risks as opportunities
• Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment, demonstrating conflict management and negotiation skills
• Partnering skills with key role such as clinical science, biostatistics and other subject matter experts (SME) at asset level to articulate and champion key decisions and strategy
• Excellent leadership skills building and managing matrixed teams, promoting motivation and empowerment of others to accomplish individual, team and organizational objectives
• Strong influencing and…