Director, Clinical Serology

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:
*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.
*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.
*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 is looking for an energetic and talented individual to join in the role of Director Clinical Serology. The incumbent will be the clinical serology technical lead for immunogenicity assessments for our ongoing and late stage clinical trials. The primary responsibility will be to provide technical guidance of clinical assay development and validation and operational support of clinical testing at CROs.   This is an exciting opportunity to join an outstanding team, with a mission to support and lead late-stage clinical serology.  The successful candidate will have the following skills and qualities:· A skilled scientist with expertise in ligand binding, functional and microbiology assays applied to vaccine programs.· A strong technical leader experienced in working with CROs involved in regulated non-clinical and clinical testing (PK/ADA, functional assays, microbiology assays, biomarker assays). · An exceptional team player who works seamlessly with others, speaks up, and remains focused on achieving the best results to attain company goals.· The ability to analyze data and communicate conclusions, decisions, and recommendations concisely to key stakeholders.· A strong sense of ownership and accountability; commitment to Vaxcyte’s mission of protecting humankind.

Essential Functions:

• Work cross functionally with program management, quality, clinical operations, regulatory, finance, and CROs to ensure accurate and on time clinical serology testing across all our programs.
• Oversight of CRO service provider(s) to ensure on time delivery of development and validation reports.
• Technical review of any documentation related to clinical serology.
• Oversight of development of new clinical serology assays to support early-stage programs.
• Support the process to select new CROs and suppliers.
• Leverage literature, industry/regulatory guidance, and practical experience to perform work and influence clinical serology strategies.
• Recommend and implement new technology that advances knowledge and productivity within the department.
• Author and review technical reports, regulatory submissions, and publications.
• Present at department, project team, and senior management meetings. May present externally at scientific conferences.

Requirements:

• PhD in Immunology /Microbiology/ Biochemistry with 6-8 years of relevant Pharma/Biotech industry experience, or Master’s degree in Immunology/Microbiology/ Biochemistry with 15+ years of relevant Pharma/Biotech industry experience.
• Experience with clinical serology for multivalent Vaccines preferred.
• Strong experience in Clinical Immunology under GLP/GXP regulations required. Understanding of Quality systems.
• Strong scientific or technological background and hands-on experience with immunoassays, bacterial functional assays, cell-based neutralization assays required.
• Sound knowledge of: Regulatory guidance applied to potency and ligand binding assays.
• Strong ability in troubleshooting equipment/technology and assay development. Excellent analytic skills. Experience in Investigations, deviations and development and implementation of CAPAs preferred.
• Strong interpersonal and leadership skills. Ability to communicate effectively both verbally and in written formats. Experience with Cross-Functional teams and managing direct reports.
• Proven technical leadership skills including strong project management skills.
• Fluency in spoken and written English is mandatory. 

Reports to: Senior Vice President, Clinical Serology