Director, Clinical Program Management

Director, Clinical Program Management

The Director, Clinical Program Management, reporting to the Head of Clinical Operations, is accountable for on-time and on-budget delivery of assigned clinical study(ies) within the RayzeBio portfolio at the highest quality standards. The role will oversee all operational aspects of the clinical program according to and in compliance with corporate and program Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) guidelines and other applicable federal (FDA) and state or regional regulations, in order to achieve established corporate goals within timelines and budget.

Job Responsibilities

Essential duties and responsibilities include the following. Other duties may be assigned :

• Develop clinical operational strategy and oversee global clinical study teams, CROs and vendors to ensure that the study(ies) are completed on time, within budget, and in compliance with RayzeBio SOPs and in adherence with ICH / GCP guidelines
• Oversee all operational aspects of clinical trial execution including planning and feasibility, start-up, conduct, close-out, and reporting
• Identify and evaluate operational risks and mitigations at a program level
• Contribute to clinical development plans and clinical protocol design
• Leads the cross-functional study execution team in achieving the study goals and deliverables
• Manages clinical study timelines and tracks, monitors and reports on study progress
• Proactively escalates issues to key internal stakeholders to ensure timely resolution of issues
• Perform oversight review and quality control of CRO and vendor scope of activities, ensuring compliance to key performance metrics and overall inspection readiness
• Active participant in CRO and vendor meetings and responsible to review key CRO and vendor study operational plans, performance data and escalations study / program risks, as needed
• Performs other related duties as assigned
• Up to 20% travel required

Education and Experience

Skills and Qualifications

Work Environment

The noise level in the work environment is usually moderate.