• Evaluate existing workflows to identify process inefficiencies, bottlenecks, and quality issues. • Develop and recommend improvements using methods such as process mapping, data analysis, and Lean Six Sigma. • Promote continuous process improvement and standardization by identifying gaps in service, training, or other processes, and drafting, developing, and/or updating business documents and requirements. • Lead or support client and internal cross-functional teams to develop and implement new processes and ensure a smooth transition. • Track key performance indicators (KPIs) and project outcomes, reporting findings and recommendations to management. • Supporting consulting with, and assisting the client with project coordination (e.g., stakeholder report), creating and maintaining program dashboard and process improvement. • Developing workflow processes to track progress and streamline operations; Assisting in the creation and establishment of a Process Asset Library, creating templates and documentation to support project management and education initiatives. • Assisting with the enterprise risk management program and training on identification, mitigations, and best practices. • Providing decision support through data gathering, information analysis, and presenting considerations to relevant stakeholders. • Conducting research and analysis to develop white papers, briefings, standard operating procedures (SOPs), Procedural Instructions (PI), and executive summaries. • Developing concise, professional, and compelling executive presentations on major initiatives. • Support organizational planning and coordination for a wide variety of summits, initiatives, and educational opportunities. • Coordinates with offsite, remote, and/or external organizations, teams, and/or vendors to conduct data calls, complete tasks, and manage initiatives. • Identifying and managing ad hoc strategic projects. • Updating and maintaining multiple client SharePoint sites, dashboards, and shared drives.

• Scheduling all Protocol-required tasks for in-life studies • Managing the department level study schedule and resources • Supporting Research Associate Supervisors, Study Supervisors, and Study Directors in scheduling • Creating the employee daily task schedule based on study schedule and departmental needs • Liaising with other departments to coordinate logistical challenges • Assisting with verification and posting of all generated schedules • Troubleshooting logistical challenges associated with workload and study execution • Maintaining consultant and contractor calendar as needed • Assisting in special projects as needed

• Proactively manage and coordinate executive calendars across multiple time zones. • Serve as the primary administrative point of contact for the executive team. • Prepare, submit, and reconcile executive expense reports. • Arrange domestic and occasional international travel logistics. • Provide flexible, as-needed support for high-priority executive projects. • Lead all logistical planning for Board of Directors and committee meetings. • Lead the planning and execution of key company events. • Directly manage and provide oversight to the onsite Operations Manager. • Manage the operational budget for the Denver and Princeton offices.

• Lead the strategic and operational oversight of all clinical and nonclinical biosample activities across the company’s development pipeline. • Building and managing end-to-end sample lifecycle processes—including collection, logistics, chain of custody, tracking, biobanking, vendor oversight, and data reconciliation. • Develop and execute the company’s global biosample management strategy across all clinical programs. • Establish scalable sample governance frameworks suitable for a small but fast-growing biotech environment. • Serve as the subject-matter expert for biospecimen regulations, GCP/GCLP standards, and evolving global requirements. • Ensure robust chain-of-custody and sample traceability systems. • Design and maintain sample management plans, laboratory manuals, and related documentation. • Partner with Translational Medicine/Research to enable biomarker strategies, assay development, and laboratory readiness. • Work with Clinical Operations to incorporate sample needs into protocol design, site training, and monitoring. • Support Biometrics and Data Management in reconciling sample data with clinical datasets. • Identify, select, and manage CROs, central labs, specialty labs, and biorepositories. • Negotiate scopes of work and oversee budget, performance metrics, and quality compliance. • Implement and monitor KPIs, SLAs, and corrective action plans when needed. • Implement or optimize LIMS/sample-tracking systems appropriate for a small biotech. • Drive continuous improvement initiatives to streamline workflows and enhance sample, visibility. • Establish and maintain SOPs, work instructions, and forms related to biosample handling. • Ensure compliance with ICH/GCP, GCLP, CLIA, CAP, GDPR, and relevant global biospecimen regulations. • Support regulatory submissions (e.g., IND, CTA, BLA) with sample-related documentation. • Prepare for and support audits and inspections related to biospecimen management. • Build and lead a high-performing biosample management team as the company grows. • Provide coaching, resource planning, and professional development for direct reports.