Director, Clinical Data Management

Systimmune; Redmond (WA); On-site; USD 190,000 - 250,000; Full time

Benefits offered by this job

100% paid employee premiums for medical/dental/vision

401(k) plan with company match

15 PTO days per year

Sick leave and 11 paid holidays

Job summary

Systimmune, a leading biopharmaceutical company in Redmond, WA, is seeking a Clinical Data Management leader. This role involves overseeing clinical trial data processes, ensuring compliance, and collaborating with various teams to ensure high-quality data management.

The ideal candidate will have at least 10 years of experience in the industry, particularly in oncology clinical trials, with proven leadership skills. This full-time position offers a competitive salary range of $190,000 to $250,000 annually and a comprehensive benefits package.

Qualifications

• Minimum 10 years of clinical data management experience.
• At least 5 years of leadership experience managing teams.
• Demonstrated experience supporting regulatory submissions.

Responsibilities

• Lead the Clinical Data Management function across the development portfolio.
• Ensure compliance with regulatory requirements and maintain inspection readiness.
• Collaborate with cross-functional teams to support study execution.

Skills

Clinical data management

Leadership

Regulatory submissions

Clinical trial databases

Problem-solving

Education

Bachelor's degree in Life Sciences, Computer Science, or related field

Master's degree (preferred)

Tools

EDC systems

CDISC standards

Job description

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, and a robust preclinical pipeline of potential cancer therapeutics in the discover and IND‑enabling stages.

We offer an opportunity for you to learn and grow while making significant contributions to the company's success.

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 offers a comprehensive benefits package including 100% paid employee premiums for medical/dental/vision, short‑term and long‑term disability, 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, 11 paid holidays, and additional benefits.

Equal Opportunity Employer

SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.