Director of Clinical Laboratory Operations
1 week ago
Vaxcyte is seeking a highly organized and detail-oriented Director, Clinical Lab Operations to join their Non-Clinical, Clinical Serology & Immunoassay Development Team. The successful candidate will be responsible for managing the sample lifecycle processes for all clinical studies, ensuring sample integrity and compliance with GCP and GDPR regulations.
Key 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 to ensure proper collection and shipment of samples.
- 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 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.
- Participate in 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.
- 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.
- 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.
Vaxcyte offers a competitive compensation package, comprehensive benefits, and an equity component. The salary range for this position is $222,000 - $237,000.
Vaxcyte is an equal opportunity employer and welcomes applications from diverse candidates. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
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