Position OverviewThe 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.
ResponsibilitiesMonitoring 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), and standardize monitoring plans, KPIs, oversight activities, and dashboards across all trials and monitoring vendors in alignment with study risk profile, phase, and complexity, including review of protocols and study document 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 rood 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, ensuring 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.
Qualifications- 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 Trail Management Systems.
- 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 with expertise in clinical monitoring methodologies (on-site, remote, centralized, and risk-based).
- Expertise in ICH-GCP, FDA, and EMA regulations, including source data verification, informed consent, and investigational product accountability.
- Strong operational acumen and project management skills with experience implementing quality management and fit-for purpose monitoring models and systems.
- Experience designing and standing up contract or FSP staffing models, including sourcing, onboarding, and performance management of contract CRAs.
- Knowledge of TMF structure, content, and quality control, including the TMF Reference Model, essential document requirements, and TMF health metrics and KPIs
- Proven ability to lead cross-functional initiatives, influence stakeholders at all organizational levels, and communicate, negotiate, and build relationships effectively.
- Ability to build, lead, and mentor high-performing teams, including recruiting, training, and retaining staff.
- Analytical mindset with a strategic approach to problem-solving and decision-making, including using monitoring data and analytics (KPIs, dashboards) to prioritize activities and resources.
- Ability to manage multiple complex projects in a dynamic environment with a high degree of professionalism, adaptability, and accountability.
Washington State Pay Range
$260,965-$309,341 USD
