Associate Director – Data and Knowledge Management

🕒 Julho 10

🏄 California – Remoto

🏄 California – Remote

💵 $183.000 - $214.000 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Diretor

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Vaxcyte

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 2013

🏥 Saúde

🏭 Manufatura

🧬 Biotecnologia

Healthcare • Manufacturing • Biotechnology

A Vaxcyte é uma empresa inovadora em vacinas em estágio clínico, projetando vacinas de alta fidelidade para prevenir e tratar infecções bacterianas graves. A empresa desenvolve vacinas conjugadas de amplo espectro e novas vacinas de proteína—utilizando química sintética moderna e uma plataforma proprietária de síntese de proteínas sem células licenciada da Sutro Biopharma—para criar antígenos de proteínas difíceis de serem produzidos de forma mais eficiente. Seus programas principais são os candidatos a vacina conjugada pneumocócica VAX-31 (31-valente) e VAX-24 (24-valente) em estudos de Fase 2/3, com candidatos em estágio inicial direcionados ao Grupo A Strep e Shigella; a Vaxcyte foca na redução da carga de doenças bacterianas invasivas, consequências da resistência a antibióticos e morbidade relacionada em populações vulneráveis.

Descrição

• Acquire and gather data from manufacturing nodes throughout the supply chain to enable regulatory filings, process monitoring, and continuous improvement. • Develop and oversee data management strategies to support operations, development, and regulatory submissions. • Own data verification for all commercial regulatory submissions. • Lead the integration of structured and unstructured data across departments (e.g., preclinical, clinical, regulatory, CMC). • Build systems and workflows to capture and retain organizational knowledge, including protocols, study results, lessons learned, and decision rationales. • Develop tools and processes that enable scientific teams to find, share, and reuse knowledge efficiently. • Champion a knowledge-sharing culture across scientific and operational functions. • Partner with regulatory, quality, R&D, IT and contract manufacturing teams to understand data and knowledge needs and align solutions. • Lead cross-functional initiatives focused on digital transformation, data harmonization, and collaboration tools. • Manage and mentor a team of data professionals, analysts, and knowledge specialists. • Ensure timely access to high-quality data for operational decision-making. • Partner with data science team to drive data visualization, reporting, and insights. • Support the use of AI/ML and automation for improved data analysis and knowledge extraction. • Ensure compliance with data protection and clinical trial regulations, including GDPR, HIPAA, and 21 CFR Part 11. • Identify and mitigate risks related to data security, access, and retention.

🎯 Requisitos

• Bachelor’s, Master’s or PhD degree in Life Sciences, Data Science, Information Management, or related field. Minimum of 9+ years of relevant experience for Ph.D., 11+ years for M.S./M.A., or 14+ years for B.S./B.A. • 8+ years of experience in data and/or knowledge management, with minimum 3 years in a life sciences or biotech setting. • Proven experience leading enterprise data governance and knowledge sharing initiatives in a highly regulated environment. • Strong project management and communication skills; able to work cross-functionally with scientific and operational teams. • Experience with tools like SharePoint, Veeva Vault, Confluence, Tableau, and SQL is highly desirable. • Experience supporting clinical trials and regulatory submissions (e.g., IND, BLA) strongly preferred. • Background in immunology, vaccines, or infectious disease R&D is highly preferred. • Experience in scaling systems and processes in a high-growth, early- to mid-stage biotech company is preferred.

🏖️ Benefícios

• The compensation package will be competitive and includes comprehensive benefits and an equity component.