Director, Clinical Development Systems & AI Analytics

Immunome, Inc.; Bothell (WA); On-site; USD 229,000 - 256,000; Full time

Job summary

Immunome, Inc. seeks a Director of Clinical Development Systems to lead the development of TMF, CTMS, and analytics platforms across multinational trials.

You will align systems investments with regulatory requirements and trial delivery needs, guiding a high-performing CDS team and coordinating with IT, QA, and external vendors. The role emphasizes governance, dashboards, and AI-enabled insights to monitor study performance, enrollment, and risk in a complex oncology portfolio.

Qualifications

• Bachelor’s degree or equivalent with 10+ years in biotech/pharma tech leadership or higher degree with 10+ years of experience.
• Experience leading technology solutions and GxP systems such as CTMS/eTMF.
• Experience delivering dashboards, automation, and decision-support tools.
• Experience enabling regulatory compliance and data integrity in clinical systems.

Responsibilities

• Lead CDS strategy for TMF and CTMS implementation and modernization.
• Oversee day-to-day vendor management and platform selection including RFPs.
• Partner with data/analytics to define KPIs, data sources, and scalable dashboards.
• Ensure systems governance, risk management, and inspection readiness across trials.

Skills

Stakeholder management

Strategic leadership

Agile methods

Data analytics

Education

Bachelor’s degree or higher

Tools

CTMS

eTMF

EDC

Job description

Immunome, Inc. seeks a Director of Clinical Development Systems to lead the development of TMF, CTMS, and analytics platforms across multinational trials.

You will align systems investments with regulatory requirements and trial delivery needs, guiding a high-performing CDS team and coordinating with IT, QA, and external vendors. The role emphasizes governance, dashboards, and AI-enabled insights to monitor study performance, enrollment, and risk in a complex oncology portfolio.