Oncology Clinical Operations Lead: Asset Strategy

GlaxoSmithKline

Upper Providence (Delaware County)

Hybrid

USD 150,000 - 210,000

Full time

9 days ago
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Job summary

GSK seeks an experienced Clinical Operations Asset Lead to represent Development Operations at asset level and at EDT/MDT, shaping the program's operational strategy and delivery.

You will coordinate clinical, biostatistics, safety, and vendors across early and late-phase oncology programs, manage resourcing and feasibility, ensure inspection readiness, and contribute to regulatory deliverables and budgeting.

Qualifications

  • Bachelor's degree in life sciences, health sciences or equivalent qualification.
  • Experience in oncology clinical operations (solid tumours and haemato-oncology).
  • Experience in oncology early-phase development (FiH/Ph1).
  • Experience in vendor management and CRO oversight.
  • Experience applying GCP and clinical development processes.
  • Experience delivering global clinical program oversight across regions.
  • Ability to manage multiple stakeholders and communicate in English (written and spoken).

Responsibilities

  • Lead and support the operational strategy and delivery for oncology programs per the clinical development plan.
  • Represent Development Operations at EDT/MDT.
  • Coordinate cross-functional inputs from clinical, biostatistics, safety, clinical supplies and vendors to meet timelines and quality.
  • Contribute to protocol development, feasibility assessments and resourcing decisions (insourcing vs outsourcing).
  • Maintain inspection readiness and quality oversight with risk management and escalation for serious breaches.
  • Provide operational input for regulatory deliverables and governance, including budgeting for clinical activities.
  • Act as a point of contact for stakeholders and vendors to ensure consistent execution across studies and sub-projects.

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
Scientific Presentations

Education

Bachelor's degree in life sciences, health sciences or equivalent qualification

Job description

GSK seeks an experienced Clinical Operations Asset Lead to represent Development Operations at asset level and at EDT/MDT, shaping the program's operational strategy and delivery.

You will coordinate clinical, biostatistics, safety, and vendors across early and late-phase oncology programs, manage resourcing and feasibility, ensure inspection readiness, and contribute to regulatory deliverables and budgeting.

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