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Senior Director, Clinical Data Management

AbCellera Biologics Inc.California, MD

Overview

Schedule
Full-time
Career level
Executive
Remote
On-site
Benefits
Health Insurance
Paid Vacation
Career Development

Job Description

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.

To apply

Please submit your application through our website and refer to Job ID 23418 in your cover letter. We receive a large volume of applications and are only able to contact those who are selected for an interview. All communication from our Talent Discovery team will come from an @abcellera.com email address.

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FAQs About Senior Director, Clinical Data Management Jobs at AbCellera Biologics Inc.

What is the work location for this position at AbCellera Biologics Inc.?
This job at AbCellera Biologics Inc. is located in California, MD, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at AbCellera Biologics Inc.?
Employer has not shared pay details for this role.
What employment applies to this position at AbCellera Biologics Inc.?
AbCellera Biologics Inc. lists this role as a Full-time position.
What experience level is required for this role at AbCellera Biologics Inc.?
AbCellera Biologics Inc. is looking for a candidate with "Executive" experience level.
What benefits are offered by AbCellera Biologics Inc. for this role?
AbCellera Biologics Inc. offers following benefits: Health Insurance, Paid Vacation, Career Development, 401k Matching/Retirement Savings, and Health & Wellness Programs for this position. Actual benefits may vary depending on the employer's policies and employment terms.
What is the process to apply for this position at AbCellera Biologics Inc.?
You can apply for this role at AbCellera Biologics Inc. either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.