Marc Tokars

Experience

1. Executive Vice President Clinical and Regulatory Affairs

   Alume Biosciences

   Jul 2024 — Present · San Diego, CA, US

   Responsible for the development program for the company’s first product, a fluorophore-peptide combination to identify nerves in various surgical settings. I have built and implemented the company’s first quality system and created policies and procedures allowing the company to internalize study monitoring and program oversight. I manage the internal clinical operations staff, maintain project timelines to ensure the timely completion of the Phase II and Phase studies. I am the primary contact with FDA and work with its Divisions in a transparent and compliant manor to ensure that our regulatory program is of high quality, on schedule and in line with FDA recommendations and guidance.

Education

• Grand Canyon University

  Master of Business Administration - MBA, Project Management

• University of Chicago

  BA, Biology

  1981 — 1986

Skills

• Clincial Operations
• Medical Devices
• Clinical Research
• CRO
• Clinical Trial Management System (Ctms)
• Oncology
• Regulatory Affairs
• Therapeutic Areas
• Ctms
• Clinical Operations
• Pain Management
• CRO Management
• Pharmaceutical Industry
• Clinical Development
• Good Clinical Practice (Gcp)
• Biotechnology
• Gcp
• Medical Affairs
• Clinical Trials
• Pharmacovigilance