Director, Clinical Data Management
About The Position
SystImmune is seeking an experienced and strategic Director, Clinical Data Management to lead the clinical data management function across our portfolio. This individual will be responsible for overseeing all aspects of clinical data management activities from study start-up through database lock and regulatory submission. The Director will provide leadership for internal and external data management teams, ensure high-quality and inspection-ready clinical data, and contribute to the development and execution of data management strategies supporting global clinical trials. The successful candidate will collaborate closely with Clinical Operations, Biostatistics, Statistical Programming, Clinical Development, Pharmacovigilance, Regulatory Affairs, and external partners to ensure timely and compliant delivery of clinical data for decision-making and regulatory submissions.
Requirements
- Bachelor's degree in Life Sciences, Computer Science, Statistics, or a related field required; Master's degree preferred.
- Minimum 10 years of clinical data management experience within the pharmaceutical, biotechnology, or CRO industry.
- At least 5 years of leadership experience managing data management teams, vendors, and CRO partnerships.
- Significant experience supporting oncology clinical trials across early- and late-stage development.
- Demonstrated experience supporting regulatory submissions (NDA, BLA, MAA) and health authority inspections.
- Expertise with EDC systems, external data integrations, data reconciliation, and database management.
- Strong knowledge of clinical trial databases, CDISC standards, coding dictionaries (e.g., MedDRA, WHO Drug), and clinical data workflows.
- Familiarity with risk-based quality management principles, GCP requirements, and clinical development processes.
- Working knowledge of biostatistics, statistical analysis, and clinical data reporting to support cross-functional collaboration.
- Proven leadership, strategic thinking, problem-solving, communication, and stakeholder management skills, with a track record of driving cross-functional collaboration and operational excellence in a fast-paced biotech environment.
Nice To Haves
- Oncology and/or antibody-drug conjugate (ADC) development experience.
- Experience managing global clinical trials across multiple regions.
- Prior experience in a growing biotechnology company.
Responsibilities
- Lead and oversee the Clinical Data Management function, including strategy, standards, processes, and operational execution across the development portfolio.
- Build and scale a high-performing data management infrastructure to support a growing clinical pipeline.
- Serve as a key cross-functional leader in clinical development planning and execution.
- Oversee all data management activities for Phase I–III clinical trials from study start-up through database lock and regulatory submission.
- Ensure the delivery of high-quality, complete, and reliable clinical data through effective data review, issue management, and quality oversight.
- Drive timely database lock and submission-ready data deliverables in accordance with study timelines.
- Ensure compliance with ICH-GCP, FDA, EMA, and other applicable regulatory requirements, while maintaining inspection readiness.
- Establish and maintain CDISC-compliant data standards and industry best practices to support regulatory submissions.
- Collaborate closely with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, and Safety teams to support study execution, data review, and submission readiness.
Benefits
- 100% paid employee premiums for medical/dental/vision
- STD
- LTD
- 401(k) plan with a 50% company match of up to 3%
- 15 PTO days per year
- sick leave
- 11 paid holidays
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What This Job Offers
Job Type
Full-time
Career Level
Director
