Senior Manager, Clinical Scientist
Replimune, Woburn
The role
Overview
Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it.
What you will do
- Facilitate and execute the creation, update, and/or review of key clinical and regulatory documents, including, but not limited to:
o Protocol concepts, synopses, protocols, and amendments
o Informed consent documents
o Investigator Brochures
o Clinical study reports
o Abstracts, posters, and manuscripts
o Clinical sections of INDs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports
o Clinical study supporting documentations and processes, e.g.: charters for (independent) safety data monitoring or steering committee, study specific management plans and manuals, SOPs, etc.