Senior / Executive Director, Clinical Site Management & Trial Operations

Benefits

Qualifications

• •Bachelor’s degree with at least 12+ years of clinical operations leadership experience
• •Experience scaling organizations; strong knowledge of global clinical development regulations
• •Expertise in clinical operations, process design, and operational excellence
• •Experience implementing clinical systems (e.g., TMF, CTMS)
• •Strong monitoring and site management leadership
• •Experience leading global teams and CROs
• •Experience supporting inspections and regulatory interactions
• •Proven people leadership, change management, and cross-functional influence
• •Strong knowledge of ICH-GCP and key regulations (FDA, EMA)
• •Deep expertise in trial execution, monitoring, and site management
• •Strategic, hands-on operator with strong execution skills
• •Excellent leadership, communication, and stakeholder management
• •Analytical, metrics-driven, and solution-oriented
• •Able to lead multiple complex programs in a fast-paced environment
• •High integrity, professionalism, adaptability, and accountability
• •12 more items(s)

Responsibilities

• •The Senior/Executive Director, Clinical Site Management & Trial Operations will build and lead Immunome’s global site management and trial operations function to deliver compliant, efficient clinical trials
• •Reporting to the SVP, Clinical Development Operations, this role owns site-facing strategy and execution across the portfolio (site engagement, training, enrollment, monitoring, and quality oversight) and leads field and in-house CRAs and CTAs
• •Partners with Project Delivery, Data Management, investigative sites, and vendors to improve site performance, protect data integrity, and deliver studies on time
• •May serve as Clinical Operations Program Lead for select programs
• •Lead global Site Management & Trial Operations; may serve as Clinical Operations Program Lead
• •Build and scale fit-for-purpose SOPs, processes, and role clarity
• •Hire, develop, and lead a high-performing team
• •Set risk-based monitoring strategy and oversight
• •Define site engagement approach to improve enrollment and execution
• •Support selection and rollout of TMF and CTMS
• •Define and track KPIs for execution, quality, and site performance
• •Drive continuous improvement in efficiency, data quality, and site experience
• •Own capacity planning and resource forecasting
• •Advise leadership on readiness for pipeline growth and M&A
• •Clinical Trial Oversight
• •Oversee trial planning and delivery to timeline, budget, and quality targets
• •Provide feasibility-focused operational input to protocols and plans
• •Identify and mitigate operational risks; implement mitigations
• •Serve as escalation point for site and trial execution issues
• •Vendor Management
• •Oversee CRO performance for site management and monitoring
• •Set partner expectations, SLAs, and KPIs
• •Monitor performance and drive corrective actions/CAPAs
• •Partner with Project Delivery on governance, reviews, and escalations
• •Support vendor selection, bid defenses, and contract review
• •Ensure compliance with ICH-GCP, regulatory requirements, and company SOPs
• •Oversee monitoring quality, study documentation, and operational compliance
• •Lead inspection readiness, audits, and follow-up actions
• •Identify systemic risks across trials/sites; drive preventive actions
• •Ensure strong oversight of TMF, CTMS, and other clinical systems
• •Cross-Functional Collaboration
• •Align with Project Delivery on milestones and execution plans
• •Partner with Data Management on data review, query resolution, and database lock
• •Coordinate with Regulatory, Safety, and Quality on reporting and compliance
• •Contribute to study governance and operational decisions
• •Drive clear communication and alignment across Clinical Development Operations
• •Budget & Resource Management
• •Support study budgets and financial forecasting
• •Monitor spend and resource utilization
• •Optimize resourcing models for efficient site oversight
• •Contribute to long-range planning and budgeting
• •38 more items(s)