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

GlaxoSmithKline; Philadelphia (Philadelphia County); On-site; USD 190,000 - 316,000; Full time

Benefits offered by this job

Health benefits

Retirement benefits

Paid holidays

Vacation

Parental leave

Job summary

GlaxoSmithKline in the United States seeks a Clinical Operations Asset Lead (COAL) for Late Phase Lung Oncology. You will translate scientific strategy into executable operational plans and serve as senior guardian of asset delivery across multiple studies and indications.

You will shape development plans, drive risk management, budget forecasting, and governance across Study Delivery Teams, with external partners and CRO oversight.

Qualifications

• Bachelor's degree in life sciences, healthcare, business or related field, or equivalent experience.
• Minimum of 10 years of pharmaceutical R&D or related industry experience.
• At least 3 years as COAL (or similar) in lung cancer indications
• 5+ years of experience managing global, complex programs with multiple studies
• Experience preparing for BLA filing and BLA inspection readiness
• Deep therapeutic area expertise in lung treatment landscape and competitive environment

Responsibilities

• Own the clinical operational strategy and end-to-end delivery of the asset
• Shape the Clinical Development Plan and Integrated Evidence Plan
• Lead asset-level operational planning and scenario modelling
• Define and oversee the asset resourcing strategy
• Provide strategic leadership across Study Delivery Teams
• Drive asset-level risk management, quality and inspection readiness
• Lead operational strategies across countries, patient engagement, diversity and study execution
• Ensure robust financial, data and stakeholder governance

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?

We are seeking professionals with the following required skills and qualifications to help us achieve our goals

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 QualificationIf 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.

#LI-GSK*

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 share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process. Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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