Director, Clinical Development Systems & AI Analytics

Doist; Bothell (WA); On-site; USD 229,000 - 256,000; Full time

Job summary

Immunome seeks a Director of Clinical Development Systems to lead the CDS program, shaping strategy and delivering TMF, CTMS, dashboards, and analytics. You will partner with Development, IT, Quality, Procurement, Finance and vendors to build a connected, inspection-ready clinical systems ecosystem that enables end-to-end visibility across studies, sites, milestones, documents, and trials.

You will mentor a high-performing CDS team and oversee vendor management, ensuring data integrity and

Qualifications

• Experience leading clinical systems and technology programs in biotech/pharma.
• Proven ability to manage enterprise platforms and budgets.
• Strong knowledge of GxP, CDISC, regulatory inspections.

Responsibilities

• Lead TMF and CTMS delivery and modernization, including processes and data migration.
• Deliver a connected clinical operations ecosystem across studies and sites.
• Partner with data/analytics to define KPIs, data sources, and scalable dashboards.
• Sponsor automation, improve data integrity, and ensure regulatory readiness.

Skills

Leadership

Clinical systems

Agile

Product ownership

Budgeting

Stakeholder management

Data analytics

GxP knowledge

Education

Bachelor’s degree or equivalent experience

Higher degree (MS/PhD) desired

Tools

CTMS

eTMF

EDC

Regulatory systems

Clinical data warehouse

Job description

Immunome seeks a Director of Clinical Development Systems to lead the CDS program, shaping strategy and delivering TMF, CTMS, dashboards, and analytics. You will partner with Development, IT, Quality, Procurement, Finance and vendors to build a connected, inspection-ready clinical systems ecosystem that enables end-to-end visibility across studies, sites, milestones, documents, and trials.

You will mentor a high-performing CDS team and oversee vendor management, ensuring data integrity and