Clinical Operations Strategy & Planning Lead Oncology
Job Purpose
The Operational Strategy & Planning Lead transforms clinical operations planning from a study-level to a dynamic, portfolio-wide strategy across clinical development plan (CDP), asset and indication levels.
Reporting to the GCO TA Head VP, this role directly impacts operational viability, optimisation, and strategic direction by supporting data-driven planning, robust operational assessments, and early solutions identification (including Recruitment, Digital Health, Representativity, Sustainability and Patient Engagement solutions).
Key Responsibilities:
1. Collaborate with Disease Area Leaders (DALs) to capture early clinical development inputs, monitor external disease risks (e.g., new approvals, reimbursement changes, competitor trials), and align assets and indications across the portfolio, while engaging in transversal initiatives with TA Heads and DALs.
2. Partner with Clinical Operations Asset Leads (COALs) to integrate commercial, regulatory, and representativity strategies that deliver data-driven CDPs.
3. Coordinate with Global Monitoring and Safety Evaluation (GMASE) budget specialists to incorporate early financial assessments, ensuring key operational decisions, including country and site selections, are both operationally robust and cost-effective.
4. Propose innovative, tech-enabled solutions, leveraging disease area insights and patient pathways to optimise recruitment, reduce complexity, and improve planning.
5. Conduct viability assessments, coordinate peer reviews, and refine CDPs to meet regulatory, commercial, and competitive priorities while managing risks.
6. Collaborate with COALs to identify internal risks (e.g., overlapping recruitment) and external risks (e.g., new approvals, reimbursement changes, competitor trials), generating actionable insights for ongoing trials and programs.
7. Support the development of an integrated reporting system linking data across indications, assets, CDPs, and studies to yield actionable insights (e.g., study results' impact on CDPs, CDP-to-BLA alignments) that optimize performance and enhance visibility.
8. Track key performance indicators to measure the function's value, using lessons learned and planned versus actual data comparisons to refine processes and improve operational baselines across teams and disease areas.
9. Provide strategic input in GCO TA leadership team discussions by standardizing operational viability assessment and planning support frameworks across disease areas while ensuring necessary tailoring.
10. Lead continuous improvement initiatives by piloting digital tools, AI/ML solutions, and predictive analytics to enhance planning accuracy, efficiency, and costs and resource management.
Basic Qualifications:
• Bachelor’s degree in a relevant field (e.g., Life Sciences, Clinical Research, Business, or related expertise).
• 7+ years of relevant industry experience, with proven expertise in Oncology.
• Demonstrated leadership in clinical development operations, CDP planning, or study feasibility roles within a global, multinational environment, such as at a CRO, pharmaceutical company, or similar organization, and the ability to thrive in ambiguous, uncertain, dynamic environments, adapting to rapidly evolving internal priorities and external insights.
• Proven experience in strategic problem-solving and an in-depth understanding of the drug development process as well as relevant industry guidelines (FDA, GCP, ICH).
• Proven experience managing portfolio-level planning across multiple disease areas and delivering strategic insights for consideration during internal governance board presentations to GSK senior leadership.
• Project management experience in a complex, matrix organization.
• Experience in analysing data from divergent sources to produce actionable, strategic recommendations.
• Experience in driving process improvements and managing handover processes between strategic planning and detailed operational execution.
Preferred Qualifications:
• Master’s or PhD degree in a relevant field.
• Knowledge of Agile methodologies.
• Experience utilizing clinical trial recruitment modeling tools and industry data sources (e.g., CiteLine, DQS, TriNetX).
• Experience spanning multiple disease areas.
• Expertise in data analysis and interpretation, visualization, and digital analytics.
• High proficiency with Microsoft Office tools.
• Strong influencing, negotiation, and communication skills.
We Offer:
• An opportunity to redefine clinical operational planning by transitioning from traditional study-level iterations to a streamlined, strategic asset, indication and CDP-level approach.
• A pivotal Director-level role with portfolio-level oversight, enabling you to influence strategic decisions at senior leadership levels.
• A collaborative and innovative environment where your leadership and strategic vision will drive continuous improvements in clinical operations planning.
Clinical Operations Strategy & Planning Lead Oncology
Job Purpose
The Operational Strategy & Planning Lead transforms clinical operations planning from a study-level to a dynamic, portfolio-wide strategy across clinical development plan (CDP), asset and indication levels.
Reporting to the GCO TA Head VP, this role directly impacts operational viability, optimisation, and strategic direction by supporting data-driven planning, robust operational assessments, and early solutions identification (including Recruitment, Digital Health, Representativity, Sustainability and Patient Engagement solutions).
Key Responsibilities:
11. Collaborate with Disease Area Leaders (DALs) to capture early clinical development inputs, monitor external disease risks (e.g., new approvals, reimbursement changes, competitor trials), and align assets and indications across the portfolio, while engaging in transversal initiatives with TA Heads and DALs.
12. Partner with Clinical Operations Asset Leads (COALs) to integrate commercial, regulatory, and representativity strategies that deliver data-driven CDPs.
13. Coordinate with Global Monitoring and Safety Evaluation (GMASE) budget specialists to incorporate early financial assessments, ensuring key operational decisions, including country and site selections, are both operationally robust and cost-effective.
14. Propose innovative, tech-enabled solutions, leveraging disease area insights and patient pathways to optimise recruitment, reduce complexity, and improve planning.
15. Conduct viability assessments, coordinate peer reviews, and refine CDPs to meet regulatory, commercial, and competitive priorities while managing risks.
16. Collaborate with COALs to identify internal risks (e.g., overlapping recruitment) and external risks (e.g., new approvals, reimbursement changes, competitor trials), generating actionable insights for ongoing trials and programs.
17. Support the development of an integrated reporting system linking data across indications, assets, CDPs, and studies to yield actionable insights (e.g., study results' impact on CDPs, CDP-to-BLA alignments) that optimize performance and enhance visibility.
18. Track key performance indicators to measure the function's value, using lessons learned and planned versus actual data comparisons to refine processes and improve operational baselines across teams and disease areas.
19. Provide strategic input in GCO TA leadership team discussions by standardizing operational viability assessment and planning support frameworks across disease areas while ensuring necessary tailoring.
20. Lead continuous improvement initiatives by piloting digital tools, AI/ML solutions, and predictive analytics to enhance planning accuracy, efficiency, and costs and resource management.
Basic Qualifications:
• Bachelor’s degree in a relevant field (e.g., Life Sciences, Clinical Research, Business, or related expertise).
• 7+ years of relevant industry experience, with proven expertise in Oncology.
• Demonstrated leadership in clinical development operations, CDP planning, or study feasibility roles within a global, multinational environment, such as at a CRO, pharmaceutical company, or similar organization, and the ability to thrive in ambiguous, uncertain, dynamic environments, adapting to rapidly evolving internal priorities and external insights.
• Proven experience in strategic problem-solving and an in-depth understanding of the drug development process as well as relevant industry guidelines (FDA, GCP, ICH).
• Proven experience managing portfolio-level planning across multiple disease areas and delivering strategic insights for consideration during internal governance board presentations to GSK senior leadership.
• Project management experience in a complex, matrix organization.
• Experience in analysing data from divergent sources to produce actionable, strategic recommendations.
• Experience in driving process improvements and managing handover processes between strategic planning and detailed operational execution.
Preferred Qualifications:
• Master’s or PhD degree in a relevant field.
• Knowledge of Agile methodologies.
• Experience utilizing clinical trial recruitment modeling tools and industry data sources (e.g., CiteLine, DQS, TriNetX).
• Experience spanning multiple disease areas.
• Expertise in data analysis and interpretation, visualization, and digital analytics.
• High proficiency with Microsoft Office tools.
• Strong influencing, negotiation, and communication skills.
We Offer:
• An opportunity to redefine clinical operational planning by transitioning from traditional study-level iterations to a streamlined, strategic asset, indication and CDP-level approach.
• A pivotal Director-level role with portfolio-level oversight, enabling you to influence strategic decisions at senior leadership levels.
• A collaborative and innovative environment where your leadership and strategic vision will drive continuous improvements in clinical operations planning.
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