Executive Director, Regulatory Affairs – Clinical European/Global Focus
Join our Mission to Protect Humankind!
Vaxcyte is a clinical-stage vaccine innovation company engineering high‑fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well‑defined, and Vaxcyte is set up to go the distance.
WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:
RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re‑innovate the way vaccines are delivered.
AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness‑first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
Summary
This leadership role is responsible for developing and implementing global regulatory strategies for clinical investigational studies and commercialization of vaccines for both adult and pediatric populations. In collaboration with Clinical Development and Safety this role is responsible for regulatory guidance that enables and facilitates the preparation of clinical development protocols, interpretation and summary of clinical results, initiation, development and preparation of clinical and pre‑clinical regulatory documents, correspondence and responses to