Senior Director, Clinical Data Management

AbCellera Biologics Inc.; San Francisco (CA); Presencial; USD 200.000 - 280.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Equity

Annual bonus

Active lifestyle allowance

Comprehensive health benefits

Descripción de la vacante

AbCellera Biologics Inc. is seeking a Senior Director of Clinical Data Management to define our global CDM strategy, build a high-performing team, and safeguard data integrity across trials.

You will lead end-to-end data management, including ED C/UAT, data cleaning, and submission readiness, while ensuring compliance with global regulations. You will partner with Clinical Development, Quality, and Biostatistics, drive vendor governance, and manage budgets to maintain study quality and timelines

Formación

• Advanced degree in Life Sciences, Statistics, Data Science, or related field.
• 10+ years of industry experience with 5+ years in people management.
• Proven leadership in building clinical data management teams.
• End-to-end data management for clinical trials including ED C/UAT.
• Strong knowledge of CDISC and data standards (CDASH/SDTM).

Responsabilidades

• Build and scale a high-performing data management team.
• Plan and manage full-lifecycle data quality and integrity across trials.
• Ensure regulatory compliance and inspection readiness.
• Partner with Clinical Development, Quality, Biostatistics, and Regulatory.
• Oversee CRO/vendor selection, governance, and performance.
• Manage vendor budgets and cost-effective solutions.
• Serve as escalation point for data management issues.

Conocimientos

Team leadership

Data quality

Regulatory audits

CRO management

Vendor management

CDISC standards

EDC systems

Database design/UAT

Cross-functional collaboration

RBQM

Educación

Master's degree in Life Sciences, Statistics, Data Science, or related field

Herramientas

CDMS platforms

Define-XML tooling

SAS

Descripción del empleo

Each of us cares about someone who will need medicines. That’s why our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients who need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown.

We’re 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.

How you might spend your days

• 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

We’d love to hear from you if

• You have 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
• You have expertise in building and leading clinical data management teams, including experience in resourcing global registrational studies
• You have 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
• You have 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
• You have 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
• You have an 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
• You have 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
• You have a desire to contribute to a culture that reflects AbCellera’s values by acting with integrity, accountability, and a team-first mentality

What we offer

• In addition to a competitive base salary, we offer equity, an annual bonus dependent on individual and company performance, and a 6% 401K contribution.
• You will have a USD $1,500 annual Active Lifestyle Allowance, annual vacation, professional development opportunities, and comprehensive health benefits. And you’ll find a strong sense of community and connections across AbCellera through our work.

About AbCellera

Creating medicines is the most important work we can do.

We are a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology. We have built a platform for advancing antibody drug programs from target to clinic, and we are using it to build our internal pipeline.Today, our pipeline includes two drug candidates in clinical development, two preclinical development candidates (DCs) in Investigational New Drug (IND)-enabling activities, and more than 20 active discovery programs across multiple modalities and indications.

We believe that when tenacious people share a vision and work together, they can truly have a positive impact. That’s why we hire for character and intelligence, not just for CVs or experience.

We look for people with drive and energy. People we trust. People who need to know their days are being well spent. That their work really matters. In the end, our success will be measured by the impact of our medicines.