Senior / Executive Director, Clinical Site Management & Trial Operations

Immunome, Inc.•Bothell, WA

4h•$265,000 - $365,000

About The Position

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.

Requirements

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.

Responsibilities

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.
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.
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.
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.
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.