Parabilis Medicines

Clinical Operations

• Accountable for delivery of assigned clinical program/trial budget, timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support trial and/or program objectives
• Develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan
• Lead and execute all trial phases based on stage of development in compliance with ICH/GCP, local regulations and Parabilis procedures
• Manage and provide oversight to the cross functional team and CRO/vendor(s) related to all aspects of clinical trial operations
• Evaluate, qualify, onboard and train vendors and investigative sites
• Review and provide clinical operations input into regulatory documents such as clinical trial protocols, informed consent forms (ICFs), investigator brochures, and study reports
• Perform and document study level Sponsor Oversight of outsourced clinical activities ensuring a trial storyboard is inspection ready
• Communicate study-status, cost and issues to ensure timely decision-making by senior management
• Oversee/collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct
• Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance
• Lead and/or participate in clinical operations workstreams related to departmental and operating model related initiatives
• Provide managerial oversight and mentorship to assigned clinical operations staff by providing clinical operations and functional area expertise and support identification and prioritization of study and program level work
• Conduct site and CRA oversight visits
• Drive trial and site level performance and engagement through regular communication, clear expectation setting, and development of action plans for issue remediation
• Develop and maintain strong relationships, including external partners such as investigators, site staff, collaborators and Key Opinion Leaders
• Program/trial budget management, reporting and forecasting activities
• Maintain current knowledge of external environment to ensure innovations (such as AI / Machine Learning) are considered and/or incorporated into clinical trial delivery strategy

Associate Director, Clinical Operations