Director, Clinical Operations Asset Lead (COAL), Late Phase Lung Oncology

GlaxoSmithKline plc; Upper Providence (Delaware County); On-site; USD 190,000 - 316,000; Full time

Job summary

GSK seeks a Clinical Operations Asset Lead (COAL), Late Phase Lung Oncology, to drive strategic operational plans across global programs. You will partner with Clinical Development, Biostatistics and partners to enable asset delivery.

You will shape development plans, manage resourcing, and ensure quality, risk mitigation and governance while leading Study Delivery Teams in a dynamic oncology portfolio.

Qualifications

• Bachelor’s degree or equivalent in life sciences, healthcare, business or related field.
• 10+ years in pharma R&D or related industry with leadership experience.
• 3+ years as COAL (or similar) in lung cancer indications.
• Experience with BLA prep and inspection readiness.

Responsibilities

• Own the clinical operational strategy and end-to-end delivery of the asset through development and lifecycle.
• Shape the Clinical Development Plan and Integrated Evidence Plan for feasibility and timely delivery.
• Lead asset-level planning, modelling timelines, cost, resources, quality and risk.
• Define asset resourcing strategy, including insourcing/outsourcing and vendor oversight.
• Provide strategic leadership across Study Delivery Teams and cross-functional coordination.
• Drive asset-level risk management, quality and GCP readiness through Quality by Design.
• Oversee regional strategies including country operations, patient engagement and technology use.
• Ensure robust governance with budget forecasting and regulatory contribution.

Skills

Analytical Thinking

Clinical Data Interpretation

Clinical Data Review

Clinical Development

Clinical Trial Designs

Clinical Trials Monitoring

Digital Fluency

Drug Regulatory Affairs

Executive Presence

Hematology and Oncology

Learning Agility

Matrix Leadership

Real World Evidence (RWE)

Scientific Presentations

Education

Bachelor's degree in life sciences, healthcare, business or a related field

Advanced degree (Master's, PhD, PharmD, MD) in a relevant discipline

Job description

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.

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:

• 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

• 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.

Skills

• Analytical Thinking
• Clinical Data Interpretation
• Clinical Data Review
• Clinical Development
• Clinical Trial Designs
• Clinical Trials Monitoring
• Digital Fluency
• Drug Regulatory Affairs
• Executive Presence
• Hematology and Oncology
• Learning Agility
• Matrix Leadership
• Real World Evidence (RWE)
• Scientific Presentations

If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $189,750 to $316,250. The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our shar