[Hiring] Senior Director, Clinical Field Monitoring and Trial Operations @Immunome

Role Description

The Senior Director, Clinical Field Monitoring and Trial Operations (FMTO) provides strategic and operational leadership for Immunome’s clinical trial monitoring function, accountable for implementing Immunome’s contract field monitoring team and standardizing monitoring strategy, oversight activities, KPIs, and dashboards across all trials and monitoring vendors to ensure site-level data quality, patient safety, and protocol compliance across Immunome’s oncology portfolio.

The Senior Director will lead and develop a high-performing field monitoring function, including a contract field monitoring team, partnering closely with Clinical Site and Trial Operations, Clinical Project Delivery Data Management, Clinical Development Systems, and Quality to ensure monitoring and TMF data, technology, and reporting enable enterprise-wide visibility into trial, site, and document performance.

The Senior Director may also take on management and development of other trial operations staff or teams to support expansion of Immunome’s trial operations capabilities as well as leading various trial oversight activities and operational initiatives.

Responsibilities

• Monitoring Strategy & Trial Oversight:
  • Own and evolve Immunome’s clinical monitoring strategy, including risk-based monitoring (RBM) and fit-for-purpose monitoring models.
  • Standardize monitoring plans, KPIs, oversight activities, and dashboards across all trials and monitoring vendors.
  • Establish monitoring standards, templates, and best practices.
  • Design and implement Immunome’s contract field monitoring team.
  • Lead monitoring oversight across Immunome's clinical portfolio from site qualification through close-out.
  • Identify and escalate site-level risks, protocol deviations, and data quality issues.
• Clinical Operations Leadership:
  • Build, lead, and mentor high-performing teams.
  • Conduct or oversee monitoring training and oversight visits.
  • Partner with Project Delivery, Clinical Site and Trial Operations, and Clinical Development Systems.
  • 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.
  • Ensure vendor compliance with contractual obligations and performance metrics.
  • Contribute to governance, vendor oversight, and quality management processes.
• 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 and audit response.
  • Drive operational excellence to ensure data integrity and consistent trial conduct.
• Cross-Functional Collaboration:
  • Partner closely with various departments to align monitoring and TMF strategy.
  • Represent Field Monitoring and TMF Oversight in governance meetings.
• Budget and Resource Management:
  • Maintain financial oversight of monitoring budgets.
  • Support Project Delivery in developing and forecasting monitoring budgets.
  • Oversee resource allocation across contract field monitoring and CTA teams.

Qualifications

• Bachelor’s degree with 14+ years of clinical monitoring experience within the biotechnology or pharmaceutical industry.
• Experience resourcing, building, and managing Clinical Monitoring Teams and related infrastructure.
• Experience defining, performing, and overseeing TMF QC activities.
• Able to travel up to 30% for in-house meetings and various monitoring activities.

Knowledge and Skills

• Deep understanding of clinical development processes, trial design, and global regulatory frameworks.
• Expertise in ICH-GCP, FDA, and EMA regulations.
• Strong operational acumen and project management skills.
• Experience designing and standing up contract or FSP staffing models.
• Knowledge of TMF structure, content, and quality control.
• Proven ability to lead cross-functional initiatives and influence stakeholders.
• Ability to build, lead, and mentor high-performing teams.
• Analytical mindset with a strategic approach to problem-solving.
• Ability to manage multiple complex projects in a dynamic environment.

Washington State Pay Range

$260,965 - $309,341 USD

E/E/O

Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

E-Verify

Immunome, Inc. is a participant in E-Verify. Please review the following notices:

• E-Verify Participation Poster
• Right to Work Poster (English)
• Right to Work Poster (Spanish)