Director, Clinical Lab Operations

4 days ago


San Carlos, California, United States Vaxcyte Full time
Director, Clinical Lab Operations

Vaxcyte is seeking a highly skilled and experienced Director, Clinical Lab Operations to join our Non-Clinical, Clinical Serology & Immunoassay Development Team. This role will be responsible for the management of the sample lifecycle processes for all clinical studies.

Key Responsibilities:
  • Collaborate with Clinical Operations study and/or project teams to develop biological sample management plans for Immunogenicity samples.
  • Interface with laboratory personnel, sample processing vendors or sites, and other vendors as needed to ensure proper collection and shipment of samples.
  • Coordinate incoming and outgoing clinical study supply shipments.
  • Ensure sample integrity and maintain GCP and GDPR compliance for samples through chain of custody, sample handling guidelines, and proper storage conditions.
  • Participate in process improvement projects (SOPs, Work Instructions, training materials).
Requirements:
  • BS/MS degree in a relevant scientific discipline with a minimum of 12 years of experience.
  • Highly organized, with exceptional attention to detail, excellent record-keeping skills, and calm under pressure.
  • Sample inventory and tracking experience, experience working with databases, and strong computer skills.
  • Excellent documentation practice and familiarity with writing SOPs and work instructions.
  • Rigorous, quantitative, and keen to maximize efficiency.

Vaxcyte is an equal opportunity employer and welcomes applications from diverse candidates. The compensation package will be competitive and includes comprehensive benefits and an equity component.



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