Executive Director, Global Operations
Michelle Gayari has more than 20 years of experience in clinical research, including career highlights at Pfizer, where she led programming across Phases I-III studies for all indications of Lyrica® and several other CNS compounds.
Her areas of expertise include rapid response to submissions and developing requirements and displays for special safety topics and integrated summary documents. Michelle’s broad experience includes several successful submissions in both the US and EU, for NDAs, MAAs, and supplements.
As Executive Director, Global Operations at MMS, Michelle leads the global technical functions for all MMS service offerings, including medical writing, biostatistics, safety, and regulatory affairs. Her teams are experienced in supporting a variety of submissions for both small and large pharma, including all aspects of clinical development—from developing EDC systems, SAPs, and protocols, to creating CDISC and integrated datasets, as well as eCTDs, for both US and EU submissions. Under her leadership, MMS teams have supported submissions that involve large amounts of legacy data through merger and acquisition (M&A) submissions with varied datasets and other scenarios.
With a focus on teamwork and mentoring at all levels, Michelle has organically built a talented and motivated team of colleagues internationally. Michelle earned her BS in Statistics, Mathematics, and Psychology from Central Michigan University. Michelle is a CDISC associate member and invited speaker at many forums, including RAPS and DIA.
“The growth that MMS has experienced since day one is truly due to the people in our offices across the world. We’ve been able to not only develop highly talented professionals but we play a critical role in the process of bringing life altering drugs to market. I like to say that “good work rises to the top,” and I am continually reminded of that every day.”
— Michelle Gayari