Director, Clinical Operations Asset Lead (COAL), Late Phase Lung Oncology
gskMillbrae (CA)
Director, Clinical Operations Asset Lead (COAL), Late Phase Lung Oncology
Posted today
gskMillbrae (CA)
SENIORITY
Manager
About the role
GSK Clinical Operations Asset Lead (COAL), Late Phase Lung OncologyGSK aims 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. We're uniting science, technology, and talent to get ahead of disease together.
Job Purpose:
The Clinical Operations Asset Lead (COAL), Late Phase Lung Oncology is accountable for the operational strategy and delivery of complex global clinical programs across the asset lifecycle. As a key member of the Medicine Development Team, the COAL translates scientific strategy into executable operational plans, partnering across Clinical Development, Biostatistics and functional experts to enable informed asset decisions. This role provides strategic leadership to Study Delivery Teams and oversees delivery across multiple studies, indications and combinations, while retaining overall accountability for successful asset delivery.
Key Responsibilities:
Own the clinical operational strategy and end-to-end delivery of the asset, from candidate commitment through development, late-phase delivery and lifecycle management. Shape the Clinical Development Plan and Integrated Evidence Plan, ensuring studies are operationally feasible, scientifically aligned and positioned for high-quality, timely delivery. Lead asset-level operational planning and scenario modelling, balancing timelines, cost, resources, quality and risk to inform governance decisions and optimize delivery. Define and oversee the asset resourcing strategy, including insourcing/outsourcing decisions, vendor selection and oversight of external delivery partners. Provide strategic leadership across Study Delivery Teams, coordinating cross-functional expertise and acting as the senior escalation point for significant operational, quality and delivery issues. Drive asset-level risk management, quality and inspection readiness, embedding Quality by Design principles and ensuring effective mitigation of operational and GCP-related risks. Lead operational strategies across countries, patient engagement, diversity and study execution, bringing innovation, technology and external insights into asset delivery. Ensure robust financial, data and stakeholder governance, including accurate budget forecasting, operational data, regulatory submission contributions and effective communication across clinical operations and asset stakeholders. Why You?
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, healthcare, business or a related field, or equivalent experience.
- Minimum of 10 years of pharmaceutical R&D or related industry experience.
- At least 3 years of experience as COAL (or similar role) in lung cancer indications 5 years + experience successfully managed global, complex programs with multiple studies
- Demonstrated experience with preparing for BLA filing (from early prep to actual filing) and BLA inspection readiness
- Deep therapeutic area expertise and solid knowledge of the lung treatment landscape and competitive environment
- Preferred Qualification If You Have The Following Characteristics, It Would Be A Plus
- Advanced degree (Master's, PhD, PharmD, MD) in a relevant discipline.
- Day-to-day fluency in using AI to accelerate trial timelines, improve data quality, evidence assurance, and reduce time spent on manual tasks.
- Experience leading global portfolios or cross-region evidence programs.
- Strong data fluency, including experience using dashboards and performance metrics to drive decisions.
- Experience with vendor oversight and partnerships with CROs, academic networks or external investigators.
- Demonstrated success delivering process improvements or digital-enabled transformation in evidence generation.
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