Senior Director, Clinical Data Management

Senior Director, Clinical Data Management role reporting to the VP of Biometrics. The leader will define and execute the global clinical data management strategy, build and grow a high-performing team, and safeguard data integrity across every phase of clinical development, acting as both a strategic and hands-on operational leader to drive data quality, standardize processes, and keep the company inspection-ready. AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in endocrinology, women's health, immunology, and oncology.

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 cross-functional partnerships with Clinical Development, Clinical Operations, Quality, and Biostatistics, and representing Clinical Data Management in key forums and enterprise initiatives; leading the selection, oversight, and performance management of CROs and specialty vendors, establishing governance, performance metrics, and communication processes; 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

Requirements

Advanced degree (Master's) 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 data management for clinical trials, including database design/build/UAT, edit checks/validation, review/reconciliation, database lock, and DM deliverables using relevant Clinical Data Manager platforms; deep understanding of data structures and integrations across EDC and connected systems (e.g., labs, IRT, eCOA, imaging), with ability to triage and resolve complex study-level issues; comprehensive knowledge of the clinical development lifecycle, data flow, and cross-functional dependencies, with a deep understanding of clinical practice and medical terminology; advanced proficiency in CDISC standards (CDASH, SDTM, Define-XML), metadata management, and controlled terminologies (e.g., LOINC); working knowledge of SOPs, ICH-GCP, 21 CFR Part 11/Annex 11, and privacy expectations, applying RBQM approaches; desire to contribute to a culture reflecting AbCellera's values of integrity, accountability, and a team-first mentality

Benefits

Competitive base salary; equity; annual bonus dependent on individual and company performance; 6% 401K contribution; USD $1,500 annual Active Lifestyle Allowance; annual vacation; professional development opportunities; comprehensive health benefits; strong sense of community and connections across AbCellera