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Director, Clinical Data Management

Systimmune

Redmond, WA

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JOB DETAILS
JOB TYPE
Full-time
SKILLS
Antibodies, Best Practices, Biology, Biostatistics, Biotech and Pharmaceutical, Cancer, Clinical Data, Clinical Data Interchange Standards Consortium (CDISC), Clinical Data Management, Clinical Support, Clinical Trial, Clinical Trial Management, Computer Science, Contract Research Organization (CRO), Cross-Functional, Data Management, Database Administration, Drug Development, Electronic Data Capture (EDC), FDA (Food and Drug Administration), GCP (Good Clinical Practices), Hematology, ICH Regulations, Industry Standards, Leadership, Maintain Compliance, Management Strategy, Marketing Authorization Application (MAA), Medical Coding, Medical Dictionary for Regulatory Activities (MedDRA), Oncology, Operations Processes, Pharmacovigilance, Phase I Clinical Trials, Phase III Clinical Trials, Problem Solving Skills, Quality Management, Reconciliation, Regulations, Regulatory Requirements, Regulatory Submissions, Risk, Sales Pipeline, Standards Strategy, Startup, Statistical Programming Languages, Statistics, Team Lead/Manager, Time Management
LOCATION
Redmond, WA
POSTED
30+ days ago
SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.

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.

This position is full-time onsite and can work out of our Redmond, WA or Princeton, NJ locations.

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. 

Qualifications
  • 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.
Preferred Qualifications
  • Oncology and/or antibody-drug conjugate (ADC) development experience.
  • Experience managing global clinical trials across multiple regions.
  • Prior experience in a growing biotechnology company.
 
Compensation and Benefits:
The expected base salary range for this position is $190,000 - $250,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s level qualifications, experience, and skills.

 
SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.
 
We offer an opportunity for you to learn and grow while making significant contributions to the company’s success.
 
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.

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Systimmune