Director, Clinical Operations Asset Lead

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.

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, on‑time delivery, while retaining full accountability for overall asset outcomes.

Key Responsibilities

• 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 asset‑level resourcing strategy (in‑house 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 asset‑level delivery plans, scenario modeling, and budget forecasts.
• Drive innovative, patient‑centric and efficient approaches to study execution.
• Represent Clinical Operations at governance boards and support clinical filing activities.
• Own the asset‑level 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.

Capabilities

• Demonstrates conceptual, analytical and strategic thinking to innovative approaches to clinical delivery.
• 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.
• Excellent leadership skills building and managing matrixed teams.
• Strong influencing and stakeholder management skills at all levels of the organization.
• Strong communication skills appropriate to the target audience.

Basic Qualifications:

• Bachelor’s degree in general science or life/health related Science Degree.
• Extensive portfolio‑level strategic experience leading and delivering complex clinical research programs.
• Expert‑level experience across end‑to‑end clinical development and the regulatory landscape.
• Proven experience navigating and strategizing across multiple regulatory pathways.
• Ability to develop and execute integrated strategic plans across multiple streams and indications.
• Excellent leadership skills within highly complex and high‑pressure environments.
• Excellent influencing and stakeholder management skills at all levels of the organization.

Preferred Qualifications:

• Masters’s Degree in General Science or life/health related Science Degree or MBA.
• Preferred experience leading or contributing to operational integration aspects of BD deals.
• Demonstrated cross‑functional collaborator with effective communication skills.

Skills

• Analytical Thinking
• Business Acumen
• Change Management
• Clinical Research
• Clinical Trial Designs
• Communication
• Decision Making
• Fostering Collaboration
• Influencing Without Authority
• Leadership
• Matrix Leadership
• Mentorship
• People Management
• Risk Management
• Strategic Thinking

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law.