Michele Weitz

WORK HISTORY

EDUCATION

SKILLS

ABOUT MICHELE WEITZ

A pragmatist on a mission to make clinical trial regulatory requirements meaningful and accessible to a tough crowd, I have worked as both an employee and consultant for pharmaceutical, biotech, and medical device companies of all sizes—from 23 to employees, in many therapeutic areas and around the world. I have developed training and presented at forums and conferences produced by organizers including Momentum Events, Fierce/ExL/QuestEx, SQA, ACRP, Advanstar|CBI, and Barnett International.As the former Executive Director of Clinical Operations Standards and Innovation at Clovis Oncology, Inc, for 7 1/2 years, I developed a talented team charged with building ethics and quality into everyday clinical trial operations. We accomplished this by creating and executing inspection preparation and participation strategies, advising on GCP compliance issues, responding to audit and inspection findings, developing SOPs and Best Practices, designing and delivering training programs, performing quality event/Serious Breach investigations and risk assessments, implementing Quality Management Systems, and acquiring/managing an eTMF platform—always with an eye toward how the regulatory requirements came to exist and why they matter to the people who must observe them. In November 2022, I returned to consulting to focus on strategic projects and advisory roles in the Clinical Research arena where I am able to share my dedication to approaching Inspection Readiness as an ongoing journey-one of building and showcasing my clients\' confidence in the ethics, integrity, and compliance of their work. I am fortunate to be continuing on with a great group of former Clovis colleagues who are now pharma & employees.Two years ago, I spent a transformative week at Psychedelic Science 2023 in Denver, absorbing the community’s passionate drive to make psychedelic-assisted therapy widely available to the mental health patients who need them most. I was fortunate to support MAPS many years ago as a quality consultant, and more recently, Lykos Therapeutics (formerly MAPS PBC) as Contract Inspection Readiness Lead, and I remain a fierce advocate for the development of psychedelics in mental health.I am equally proud to enthusiastically support other clients in various disciplines and therapeutic areas. Professional Credentials: RQAP-GCP (20••••15, 2018-present), CCRA (19••••07)