Prilenia

Clinical Operations

• Provide strategic direction and operational leadership for pivotal global clinical programs, ensuring rigorous execution across regions and therapeutic areas to deliver studies on time, within budget, and to the highest quality standards.
• Lead clinical operations aspects of clinical programs, including planning, coordination, delegation, communication and stepping into direct action as necessary to make sure goals are achieved on time and on budget. Provide operational insight into feasibility, timeline and cost estimates during clinical program/study development.
• Accountable for the successful delivery and inspection readiness of complex global pivotal trial/s; own operational timelines, budget management, enrollment performance, data quality, and risk mitigation.
• Lead clinical study team/s including both internal and external stakeholders, fostering accountability, collaboration and operational excellence.
• Develop and oversee effective and efficient clinical study plans in partnership with internal and external stakeholders.
• Patient Recruitment: Oversee site and investigator relationships, leading the implementation of innovative patient recruitment and retention strategies, and ensuring proactive problem-solving and stakeholder engagement across diverse populations.
• Quality: Ensure clinical monitoring quality and ongoing adherence to established study plans and GCP requirements. Partner with Regulatory, QA and other relevant teams to continuously improve clinical SOPs.
• Closely collaborate with Regulatory, Quality, Safety, Data management and clinical supply to integrate cross-functional insights into operational execution and optimize delivery of clinical supplies, data, and patient safety.
• Build and sustain strong cross-functional relationships across diverse global teams; foster a culture of mutual accountability, collaboration, and innovation.
• Communicate progress, risks, and strategic insights to executive leadership and governance committees, supporting data-driven decision-making and program advancement.

Executive Director, Clinical Operations