Director, Clinical Lab Operations

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, periodontitis 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: Vaxcyte has an exciting opportunity for a Director, Clinical Lab Operations to join their Non-Clinical, Clinical Serology & Immunoassay Development Team.  Reporting into the Sr. Vice President, Clinical Serology, Nonclinical & Immunoassay Development, the Director, Clinical Lab Operations will be responsible for the management of the sample lifecycle processes for all clinical studies.  

Essential Functions:

• 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.

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.

Reports to: Senior Vice President, Clinical Serology, Nonclinical & Immunoassay Development Location: San Carlos, CA/ Open to Remote Compensation:The compensation package will be competitive and includes comprehensive benefits and an equity component. Salary Range: $222,000 – $237,000  Vaxcyte, Inc. 825 Industrial Road, Suite 300San Carlos, CA 94070 We are an equal opportunity employer. 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. Apply