Senior Director, Clinical Field Monitoring and Trial Operations

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates.

Responsibilities

• Monitoring Strategy & Trial Oversight
  • Own and evolve Immunome’s clinical monitoring strategy, including risk-based monitoring (RBM) and fit-for-purpose monitoring models (on-site, remote, and centralized).
  • Standardize monitoring plans, KPIs, oversight activities, and dashboards across all trials and monitoring vendors in alignment with study risk profile, phase, and complexity.
  • Review protocols and study documents for monitoring and trial operations feasibility.
  • Establish monitoring standards, templates, and best practices, including monitoring plan and report templates, and monitoring oversight programs.
  • Design and implement Immunome’s contract field monitoring team, including staffing model, sourcing, onboarding, and oversight framework.
  • Lead monitoring oversight across Immunome's clinical portfolio from site qualification through close-out, ensuring monitoring visits, source data verification, reporting, and issue resolution meet timelines, quality standards, and regulatory expectations.
  • Identify and escalate site-level risks, protocol deviations, and data quality issues; drive root cause analysis and corrective and preventative actions (CAPAs).
• Clinical Operations Leadership
  • Build, lead, and mentor high-performing teams.
  • Conduct or oversee monitoring training and oversight visits to ensure consistent monitor performance and data quality across studies.
  • Partner with Project Delivery, Clinical Site and Trial Operations, and Clinical Development Systems to support study and vendor oversight.
  • Ensure inspection readiness across trials through QC reviews, KPI monitoring, and ongoing issue identification, trend analysis, and resolution.
  • Support long-term resource planning and department growth.
  • Champion a culture of accountability, collaboration, and continuous improvement.
• Vendor and CRO Management
  • Lead selection, management, and oversight of contract field monitoring staffing partners and vendors with delegated monitoring responsibilities.
  • Ensure consistent quality, performance, and KPIs across all contract monitors and CRO-provided monitors.
  • Ensure vendor compliance with contractual obligations, timelines, monitoring quality standards, and performance metrics.
  • Contribute to governance, vendor oversight, and quality management and improvement processes for effective monitoring activities.
• Quality Assurance and Regulatory Compliance
  • Ensure monitoring and TMF activities adhere to ICH-GCP, FDA, EMA, and global regulatory requirements.
  • Partner with Quality Assurance on inspection readiness, audit response, and corrective actions related to monitoring, TMF, and site-level findings.
  • Drive operational excellence to ensure data integrity and consistent trial conduct.
• Cross-Functional Collaboration
  • Partner closely with Project Delivery, Clinical Site and Trial Operations, Clinical Development, Clinical Data Management, and Clinical Development Systems to align monitoring and TMF strategy, data flow, and technology (CTMS, eTMF, and risk-based monitoring/analytics platforms).
  • Represent Field Monitoring and TMF Oversight in governance meetings and provide operational input into strategic decisions.
• Budget and Resource Management
  • Maintain financial oversight of monitoring budgets, and monitor contract scope and activities, whether conducted by in-house teams or outsourced.
  • Support Project Delivery in developing and forecasting monitoring budgets.
  • Oversee resource allocation across contract field monitoring and CTA teams to optimize costs, team performance, and deliver milestones on time.

Requirements

• Bachelor’s degree with 14+ years of clinical monitoring experience within the biotechnology or pharmaceutical industry, or equivalent combination of degree and years of experience.
• Experience resourcing, building, and managing Clinical Monitoring Teams and related infrastructure – SOPs, template reports, plans, as well as contributing to the design and implementation of Clinical Trial Management Systems.
• Experience defining, performing, and overseeing TMF QC activities.
• Able to travel up to 30% for in-house meetings and various monitoring activities.

Skills

• Bachelor’s degree with 14+ years of clinical monitoring experience within the biotechnology or pharmaceutical industry.
• Associate’s degree or equivalent with 16+ years of relevant experience.
• Experience resourcing, building, and managing Clinical Monitoring Teams and related infrastructure – SOPs, template reports, plans, as well as contributing to the design and implementation of Clinical Trial Management Systems.
• Experience defining, performing, and overseeing TMF QC activities.
• Able to travel up to 30% for in-house meetings and various monitoring activities.

Pay

Washington State Pay Range $260,965—$309,341 USD