Remote Director Clinical Lab Operations
at Vaxcyte

Summary

Join our Mission to Protect Humankind!. Vaxcyte has an exciting opportunity for a Director, Clinical Lab Operations to join their Non-Clinical, Clinical Serology & Immunoassay Development Team.

Requirements

• BS/MS degree in 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
• Excellent written and verbal communication skills to work with project and departmental teams
• Innovative, proactive, and collaborative team player
• Able to meet project deadlines and work efficiently in a fluid environment
• Experience with biological data platforms such as Benchling, database building, and integration is preferred
• Working knowledge of FDA & ICH/GCP regulations and clinical laboratory specimen handling
• Technical knowledge to maintain electronic files and experience with database entry (e.g. LIMS, excel) required
• Ability to work effectively in a cross-functional team matrix environment Entrepreneurial spirit with “can do” attitude, commitment to teamwork, and initiative

Responsibilities

• Collaborate with Clinical Operations study and/or project teams to develop biological sample management plans for Immunogenicity samples
• Collaborate with clinical study sites, Contract Research Organizations (CROs), and Central Laboratories
• Review and provide feedback on Clinical study protocols, informed consents, laboratory documents, case report forms, and service provider laboratory scope of work documents for sample handling details
• Interface with laboratory personnel, sample processing vendors or sites, and other vendors as needed to ensure proper collection and shipment of samples, respond to issues/queries as needed, and to ensure study objectives are met
• Coordinate incoming and outgoing clinical study supply shipments
• Assist in the development and maintenance of a central biorepository database (e.g. Laboratory Information Management System)
• Ensure sample integrity and maintain GCP and GDPR compliance for samples through chain of custody, sample handling guidelines, and proper storage conditions
• Participates and/or leads process improvement projects (SOPs, Work Instructions, training materials)
• Be accountable for sample location identification, check-in and check-out processes, and maintenance of up-to-date inventories
• Act as a central communication hub to coordinate and proactively identify and implement strategies to increase the effectiveness of biological sample management, including improved sample accessibility and operational efficiency
• Coordinate and support sample-related activities across CROs and identify CROs to assist in sample management