Deborah (Debbie) Ingenito
About Deborah (Debbie) Ingenito
Deborah (Debbie) Ingenito is the Associate Director, Central Monitoring Lead at Bristol Myers Squibb, with extensive experience in clinical trial management and risk-based quality management.
Current Role at Bristol Myers Squibb
Deborah Ingenito currently serves as the Associate Director, Central Monitoring Lead at Bristol Myers Squibb. In this role, she manages a team of centralized monitors, overseeing their activities and performance. Additionally, Deborah supports the oversight of clinical trial execution with external partners and serves as the operational lead for relationships with key CROs and FSPs. Her responsibilities include the development of partnership operational documents and assessing portfolio resource demands.
Experience at Celgene
Deborah Ingenito has an extensive history at Celgene, where she held multiple roles over the years. From 2017 to 2019, she served as the Associate Director of Risk Management and Strategic Monitoring. Before this, she was the Strategic Intelligence Manager for five months in 2017. She also held the position of Senior Clinical Trial Manager from 2007 to 2017, and Clinical Trial Manager from 2003 to 2007. Her earlier role at the company as a Strategic Trial Manager highlights her deep expertise in clinical trials and strategic monitoring.
Technology Expertise in Centralized Monitoring
Deborah Ingenito possesses extensive experience with a variety of technologies that support centralized monitoring. Her technological expertise includes CSA, SpotFire, JReview, TSDV, RaveEDC, ClinRO, ePRO, wearables, and various apps. These tools and platforms are integral to the processes she oversees in her current role at Bristol Myers Squibb. They enable efficient monitoring and management of clinical trials, ensuring high-quality and compliant execution.
Career at Pharmacia and Other Companies
Before her tenure at Celgene, Deborah Ingenito worked at Pharmacia as a Study Manager from 2000 to 2003. She also held positions as a Clinical Research Specialist at ClinForce and as a Clinical Research Associate at H L Yoh Scientific. Her early career includes a role as Clinical Research Associate/Regulatory Affairs Associate at Schiff & Company from 1997 to 1999. These roles provided her with a strong foundation in clinical research and regulatory affairs.
Specializations and Strategic Roles
Deborah Ingenito is highly specialized in various strategic and operational areas, including corporate acquisitions, IND transfers, joint ventures, in-licensing, collaborative and cooperative groups, and transformational change leadership. She has led the development of an end-to-end Risk Based Quality Management (RBQM) strategy, which encompasses people, processes, and technology. Her experience also includes project management, global trial management, clinical science, CQA, GMP auditing, CRA, drug supply management, risk management, and data management.