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AbCellera Biologics

Antibody discovery and licensing platform

Senior Director - Clinical Data Management

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeCalifornia, USANo salary listedIn-person

About the Job

Requirements

  • An advanced Master's degree in Life Sciences, Statistics, Data Science, or a related quantitative field, at least 10 years of industry experience, and at least 5 years as a people manager.
  • Expertise in building and leading clinical data management teams, including resourcing global registrational studies.
  • Deep experience leading end-to-end clinical-trial data management, including database design, build and user acceptance testing; edit checks and validation; review and reconciliation; database lock; and design, validation, and maintenance of data management deliverables using relevant Clinical Data Manager platforms and enabling technologies.
  • Deep understanding of data structures and integrations across electronic data capture and connected systems such as laboratories, interactive response technology, electronic clinical outcome assessment, and imaging, with the ability to triage and resolve complex study-level issues and maintain data integrity across internal systems and service providers.
  • Comprehensive knowledge of the clinical development lifecycle, data flow, and cross-functional dependencies across Clinical Operations, Biostatistics, Safety, Data Standards, and Regulatory, supported by an understanding of clinical practice and medical terminology.
  • Advanced proficiency in Clinical Data Interchange Standards Consortium standards, including Clinical Data Acquisition Standards Harmonization, Study Data Tabulation Model, and Define-XML; metadata management; and controlled terminologies such as Logical Observation Identifiers Names and Codes.
  • Working knowledge of Standard Operating Procedures, International Council for Harmonization Good Clinical Practice, 21 CFR Part 11 and Annex 11, and privacy expectations; apply risk-based, data-driven approaches to prevent or mitigate issues.
  • Act with integrity and accountability and demonstrate a team-first mentality.

Responsibilities

  • Build and scale a high-performing Clinical Data Management team, drive team performance, allocate resources, and develop talent to support a growing pipeline of early- and late-stage programs in women’s health, oncology, and endocrinology.
  • Plan and manage full-lifecycle clinical data quality and integrity across all trials, including electronic case report form builds, edit checks, external data integrations, reconciliations, data cleaning, database locks, and submission readiness.
  • Drive compliance with global regulatory standards and internal Standard Operating Procedures, support regulatory audits, and maintain inspection readiness.
  • Cultivate cross-functional partnerships with Clinical Development, Clinical Operations, Quality, and Biostatistics, and represent Clinical Data Management in cross-functional forums and enterprise initiatives.
  • Lead selection, oversight, and performance management of contract research organizations and specialty vendors; establish governance, performance metrics, and communication processes to ensure quality execution and accountability.
  • Manage vendor budgets and identify cost-effective solutions without compromising quality or compliance.
  • Serve as the primary escalation point for clinical data management issues affecting study quality, timelines, or regulatory readiness.

About the Company

AbCellera Biologics

Antibody discovery and licensing platform

AbCellera Biologics helps other companies and research teams find and develop antibody therapies. It uses a proprietary technology platform to identify antibody candidates and collaborates with pharmaceutical and biotech partners to accelerate drug discovery and development. The company's products are the antibody candidates and discovery services it provides under licensing or collaboration agreements, as well as its own internal therapeutic programs. Unlike many competitors, AbCellera emphasizes tackling difficult drug targets and building long-term partnerships with a wide range of clients, using data-driven, multidisciplinary approaches to speed up discovery. The goal is to deliver safe, effective antibody medicines to patients by advancing partner programs and its own pipeline through discovery, licensing, and development.

Company size
501-1,000
Company stage
IPO
Headquarters
Vancouver, Canada
Founded
2012

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