With over 20 years of progressive technology and people management experience, I am a Director of Clinical Development Technologies at Amgen. I currently lead the technology platform function under the global development organization, with responsibility for managing clinical development platforms, exploring new technical capabilities, facilitating process improvements, and supporting internal and external audits and inspections.I have a proven track record of delivering innovative and cost-effective technology solutions to the business, such as the trial master file (TMF), study start up, clinical site interfacing systems and processes, cloud support, virtualization, automation, and system/process disaster recovery. I have also successfully planned and executed multiple large transformations involving people, process, and technology, aligning with business goals and industry trends. I have extensive experience in leading globally distributed teams in designing, developing, and delivering highly effective and regulated systems and processes to meet and exceed business needs. I have also demonstrated excellent communication and engagement skills with executive management to formulate and deliver short, medium, and long-term strategies.
Listed skills include Sdlc, Change Control, Cross Functional Team Leadership, 21 Cfr Part 11, and 22 others.