Director, Device Development And Commercialization Lead

Vaxcyte Inc

San Carlos, United States
$219,000 - $256,000 py
On-site
Combination product design control
Late-stage development
Pre-filled syringe development
Vaxcyte Inc is seeking a Director of Device Development and Commercialization Lead to oversee the development and regulatory processes of their complex vaccine product, VAX-31. This role requires significant experience in leading device development projects, particularly with combination products like pre-filled syringes, and involves collaboration with various teams to ensure compliance and success in commercialization

Job Summary

  • Lead combination device development activities through clinical development, tech transfer, commercial manufacturing, registration, launch and post market surveillance.
  • Responsible for development of design control documents and maintaining design history file (DHF) and Device Master Record (DMR) for the Vax-31 vaccine product.
  • This is a unique opportunity to be involved in arguably the most complex Drug Product to enter clinical testing and commercial readiness, be a crucial part of late stage enablement and long-term commercial success, which will affect millions of lives globally.

Matching Summary

Match Score: 85

Vaxcyte Inc is seeking a Director of Device Development and Commercialization Lead to oversee the development and regulatory processes of their complex vaccine product, VAX-31. This role requires significant experience in leading device development projects, particularly with combination products like pre-filled syringes, and involves collaboration with various teams to ensure compliance and success in commercialization.

Salary

$219,000 - $256,000

Skills & Requirements

Must-have

  • Combination product design control
  • Late-stage development
  • Pre-filled syringe development
  • Regulatory submissions
  • GxP manufacturing environments

Nice-to-have

  • Adjuvanted vaccines experience
  • Vaccine space expertise
  • Creative and intellectual diversity
  • Kindness-first, inclusive approach

Key Requirements

  • PhD with 10+ years, MS with 12+ years, or BS with 16+ years of leadership experience
  • Experience leading device development projects
  • Significant experience in managing Design Control programs
  • Experience with PCV/adjuvanted vaccines
  • Track record of working seamlessly within and across Teams

Work Rights

Not specified

Tailored Resume

Cover Letter