Clinical Development & Regulatory Affairs Intern

Labrys Biologics is a private, venture-financed development stage biotechnology company located in San Mateo, CA focused on treatments for chronic migraine. The company is currently seeking an intern to work with its clinical development functional team leaders to support the launch of Labrys' early stage clinical trials. In this role, the candidate will gain exposure to regulatory, quality, clinical operations and drug manufacturing ramp up efforts for Labrys' lead candidate, LBR-101, which is an anti-CGRP monoclonal antibody for the treatment of chronic migraine slated to enter Phase 2 clinical trials in 2013.

Position Duties:

•Assist with setting up logistics for projects related to clinical, regulatory and non-clinical activities.
•The candidate/intern may be authorized, under supervision, to provide communications to outside vendors related to projects noted above (except to regulatory agencies)
•May review and analyze documents and data for consistency, coherence and adherence to regulatory standards
•Assist in setting up design tools and presentations using various MS office applications (Word, Excel, Powerpoint, Project)
•Assist in reviewing, tracking and analyzing adherence of vendors to contracted activities and milestones