Sr. Clinical Operations Manager

Join Lumen Bioscience as a Senior Clinical Operations Manager to plan, execute and continuously improve clinical operations across multiple clinical studies. In this strategic, cross-functional role, you’ll lead operational strategy and execution for one or more clinical development programs, oversee CRO and vendor selection and performance, manage study budgets and timelines, ensure regulatory readiness and inspection response, and support the career development of the operations team while being accountable for delivering high-quality data on time and on budget.

This position combines program ownership and strategy, team leadership, CRO and vendor management, budget and resource ownership, quality and compliance, clinical trial execution, data and documentation, process improvement and SOPs, and cross-functional leadership. You’ll create program timelines, resourcing plans, and run-rate forecasts; manage vendor KPIs and SLAs and drive performance improvements; own program budgets and control spend; ensure inspection readiness and lead remediation after audits; oversee site selection and activation, enrollment performance, monitoring strategy, and vendor deliverables; ensure eTMF completeness and adherence to GCP/ICH and applicable regulations; and drive continuous improvement and implementation of SOPs and automation to increase efficiency and quality while presenting program status to leadership and the executive team.

If you bring deep clinical operations experience, strong leadership, communication, negotiation and problem-solving skills, and a passion for advancing clinical development programs, we encourage you to apply.

• →Program Strategy & Execution: 
  • →Lead operational strategy and execution for one or more clinical development programs (Phase I–III or platform trials).
  • →Create program timelines, resourcing plans, and run-rate forecasts.
  • →Oversee site selection/activation strategy, enrollment performance, monitoring strategy (RBM), SIVs, close-out, and vendor deliverables.
  • →Escalate and resolve issues that threaten timelines or data quality.
• →Team & Vendor Leadership: 
  • →Mentor Clinical Ops Managers/CRAs; recruit, mentor, and develop talent; run performance reviews and succession plans.
  • →Manage vendor KPIs/SLAs, run vendor governance, and drive performance improvements.
  • →Hold CROs accountable for timelines, data quality, monitoring, and TMF completeness.
• →Budget & Resource Management: 
  • →Own program budgets; provide accurate forecasting and control spend.
  • →Approve study-level operational expenses within delegated authority.
• →Quality, Compliance & Documentation: 
  • →Ensure inspection readiness and lead remediation after internal or external audits.
  • →Accountable for issues escalation and coordination of inspection/agency responses.
  • →Ensure eTMF completeness, timely monitoring visit documentation, query resolution, and adherence to GCP/ICH and applicable regulations (FDA, EMA, local).
  • →Work closely with Data Management and Safety to ensure integrated delivery.
• →Process Improvement & Cross-Functional Leadership: 
  • →Drive continuous improvement; implement SOPs and automation (CTMS/EDC/eTMF optimizations) to increase efficiency and quality.
  • →Present program status to leadership and the executive team.

• Education and Experience:
  • MS/PharmD/PhD preferred; BS with robust experience considered
  • Minimum of 12 years of clinical operations experience, including program/CRO oversight and people management
  • Demonstrated ownership of Phase I–III trials and experience supporting IND/CTA filings
  • Experience in biologics or oral/edible drug delivery modalities
  • Prior inspection response ownership or regulatory submission leadership
• Skills and Attributes:
  • Strong working knowledge of CTMS, eTMF, EDC platforms
  • Proficiency in clinical trial management systems (CTMS), electronic data capture (EDC) systems, and other relevant software applications
  • Deep familiarity with ICH-GCP, FDA/EMA regulations and inspection processes
  • Strong leadership, communication, negotiation and problem-solving skills
  • ACRP or SOCRA certification

• Ability to work on-site in Seattle, WA
• Ability to sit for extended periods of time (2 or more hours)