Peter De Simone
About Peter De Simone
Peter De Simone serves as the Associate Director of Clinical Operations at Insmed Incorporated, where he oversees the execution of clinical trials and manages vendor relationships. He has extensive experience in clinical operations, having held various roles in organizations such as Celgene and Schering over the past two decades.
Current Role at Insmed
Peter De Simone serves as the Associate Director of Clinical Operations at Insmed Incorporated, a position he has held since 2021. In this role, he manages and supervises the operational aspects of clinical trials, ensuring effective oversight of vendors, including Contract Research Organizations (CROs), central labs, and clinical trial sites. He also participates in investigator meetings, kick-off meetings, and various vendor meetings to facilitate communication and collaboration among stakeholders.
Previous Experience at Insmed
Prior to his current role, Peter De Simone worked at Insmed as the Associate Director of Trial Master File (TMF) Operations from 2020 to 2021. In this capacity, he contributed to the management of clinical trial documentation and compliance, ensuring that all necessary records were maintained accurately and efficiently. His experience at Insmed spans a total of three years, including his current position.
Professional Background in Clinical Operations
Peter De Simone has extensive experience in clinical operations, having held various positions at notable organizations. He worked at Celgene as Associate Manager in Project Management Operations from 2011 to 2017, and as Associate Manager in Human Resources from 2017 to 2018. His earlier roles at Schering included Supervisor of Logistics and Senior Group Leader for TMF Clinical Documentation, where he oversaw documentation processes and logistics operations.
Education and Expertise
Peter De Simone holds a Bachelor of Science (BS) degree in Marketing from Kean University. His educational background complements his extensive experience in clinical operations, where he has developed expertise in clinical trial protocols, vendor management, and compliance oversight. This combination of education and practical experience supports his current responsibilities in managing clinical trials effectively.
Clinical Trial Management Responsibilities
In his role as Associate Director of Clinical Operations, Peter De Simone participates in the development of clinical trial protocols, amendments, and recruitment materials. He oversees the day-to-day execution of clinical trials, focusing on site start-up, patient enrollment, monitoring, compliance, and data flow metrics. His leadership in the selection and contract review process for CROs and other vendors is crucial for the success of clinical operations.