Senior Director, Clinical Data Management

AbCellera•San Francisco, CA

About The Position

We are looking for an experienced Clinical Data Management leader to join us as Senior Director, Clinical Data Management. Reporting to the VP of Biometrics, you’ll define and execute our global clinical data management strategy, build and grow a high-performing team, and safeguard data integrity across every phase of clinical development. As both a strategic and hands-on operational leader, you’ll drive data quality, standardize processes, and keep us inspection-ready at all times. If you’re energized by building something from the ground up and want your work to directly shape the quality of our clinical programs, we’d love to hear from you.

Requirements

An advanced degree (Master’s) in Life Sciences, Statistics, Data Science, or a related quantitative field with 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 experience in resourcing global registrational studies
Deep experience leading end-to-end data management for clinical trials, including database design/build/UAT (User Acceptance Training), edit checks/validation, review/reconciliation, database lock, and the design, validation, and maintenance of DM (Data Management) deliverables using relevant Clinical Data Manager platforms and enabling technologies
A deep understanding of data structures and integrations across EDC (Electronic Data Capture) and connected systems (e.g., labs, IRT [Interactive Response Technology], eCOA [electronic Clinical Outcome Assessment], imaging), with a demonstrated ability to triage and resolve complex study-level issues to maintain data integrity across internal systems and service providers
A comprehensive knowledge of the clinical development lifecycle, data flow, and cross-functional dependencies (Clinical Operations, Biostatistics, Safety, Data Standards, Regulatory), supported by a deep understanding of clinical practice and medical terminology
Advanced proficiency in CDISC (Clinical Data Interchange Standards Consortium) standards (CDASH [Clinical Data Acquisition Standards Harmonization], SDTM [Study Data Tabulation Model], Define-XML), metadata management, and controlled terminologies (e.g., LOINC [Logical Observation Identifiers Names and Codes]) to ensure consistency and submission readiness
A working knowledge of SOPs (Standard Operating Procedures), ICH-GCP (International Council for Harmonization – Good Clinical Practice), 21 CFR Part 11/Annex 11, and privacy expectations, applying risk-based, data-driven approaches (RBQM [Risk Based Quality Management]) to prevent or mitigate issues
A desire to contribute to a culture that reflects AbCellera’s values by acting with integrity, accountability, and a team-first mentality

Responsibilities

Building and scaling a high-performing Clinical Data Management team; driving team performance, resource allocation, and talent development to support a rapidly growing pipeline of early and late stage programs in women’s health, oncology, and endocrinology
Actively planning and managing full-lifecycle clinical data quality and integrity across all trials (including eCRF builds, edit checks, external data integrations, reconciliations, data cleaning, database locks, and submission readiness)
Driving strict compliance with global regulatory standards and internal SOPs while supporting regulatory audits and maintaining inspection readiness
Cultivating strong cross-functional partnerships with Clinical Development, Clinical Operations, Quality, and Biostatistics, and representing Clinical Data Management in key cross-functional forums and enterprise initiatives
Leading the selection, oversight, and performance management of CROs and specialty vendors, establishing governance, performance metrics, and communication processes to ensure high-quality execution and accountability
Managing vendor budgets and identifying cost-effective solutions without compromising quality or compliance
Serving as the primary escalation point for clinical data management issues affecting study quality, timelines, or regulatory readiness