MR

Malathi Robaina

Senior Director Clinical Operations at Rezolute

Malathi Robaina has a diverse and extensive work experience spanning over two decades in the field of clinical operations and research. Malathi began their career in 1995 as a Research Scientist at the University of Minnesota and VA Hospital, where they worked until 1998. Robaina then joined the University of Colorado Health Science Center as a Research Scientist from 1998 to 2001.

In 2002, Robaina transitioned to industry and joined Boston Scientific as a PreClinical Research Associate. During their time there, they managed pre-clinical trials focused on intravascular cardiology devices, contributing to device development, FDA submission, and commercialization. Malathi remained with Boston Scientific until 2006.

From 2006 to 2010, Robaina worked at Medtronic as a Clinical Research Manager. In this role, they served as a Program Manager for multiple concurrent clinical trials in the Endovascular field. Their responsibilities included building effective teams, providing direction to study managers and supporting team members, and identifying strategies for improved clinical research quality.

Robaina joined BioMarin Pharmaceutical Inc. in 2010 as a Clinical Project Manager. In this role, they managed clinical trials for the Phenylketonuria (PKU) program, ensuring compliance with study protocols, internal quality systems, and regulatory requirements. Malathi also mentored and provided career growth opportunities for their direct reports.

From 2012 to 2016, Robaina worked at FibroGen, Inc. as an Associate Director of Clinical Operations. During their tenure, they played a key role in managing clinical programs and operations. Malathi then transitioned to the role of Director of Clinical Operations at Sunesis Pharmaceuticals, Inc. from 2017 to 2019.

Robaina's most recent position is with Rezolute, Inc., where they have held the roles of Director of Clinical Operations since July 2019 and Senior Director of Clinical Operations since January 2022. In these positions, they have contributed to the strategic planning and execution of clinical operations activities.

Overall, Robaina's work experience showcases their expertise in clinical operations, project management, team leadership, and regulatory compliance. Their diverse background in both academic and industry settings highlights their adaptability and strong commitment to advancing healthcare through innovative clinical research.

Malathi Robaina attended Carleton College. However, no information is available regarding the specific dates of attendance, degree obtained, or field of study pursued.

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Previous companies

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Timeline

  • Senior Director Clinical Operations

    January, 2022 - present

  • Director Clinical Operations

    July, 2019

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