Director, Clinical Development Systems
Immunome, Inc.
August 07, 2026
Remote friendly (Bothell, WA)
United States
Clinical Research and Development
Position Overview
Director, Clinical Development Systems (CDS) provides strategic and operational leadership of clinical systems for the Development function, including Trial Master File (TMF), Clinical Trial Management System (CTMS), reporting, AI-enabled dashboards, and KPI analytics. Partners cross-functionally (Development, IT, Quality, Procurement, Finance, external vendors) to deliver connected, inspection-ready, business-aligned capabilities and oversee a CDS team.
Responsibilities
- Serve as clinical systems leader; provide operational input on technology strategy, enterprise platforms, delivery options, and vendor solutions.
- Develop and maintain a multi-year systems roadmap aligned to business priorities, regulatory compliance, patient impact, and measurable value.
- Recommend and establish governance forums for prioritization, scope/risk management, adoption, and sustainment.
- Champion AI-enabled dashboards and advanced analytics for portfolio health, site performance, monitoring quality, TMF health, issue resolution, and operational risk.
- Manage business cases, budgets, vendor delivery, strategic sourcing inputs, and value realization.
- Lead TMF/CTMS implementation and modernization (process design, configuration, data migration, integration validation, training, adoption, change management).
- Deliver a connected clinical operations ecosystem from study start-up through closeout.
- Define trusted KPIs, data sources, quality standards, access controls, reporting needs, and scalable dashboards.
- Simplify manual tracking, reduce duplicate data entry, automate processes, and strengthen data integrity.
- Lead vendor/platform selection (RFPs, evaluations, business cases) and day-to-day vendor management.
- Ensure adherence to ICH-GCP, FDA, EMA, and global regulatory requirements; partner with Quality on validation, audits/inspections, corrective actions; drive data integrity.
- Maintain financial oversight; build and mentor the CDS team; support project and vendor teams; promote innovation, excellence, and continuous improvement.
Qualifications
- Bachelor’s degree (or equivalent) with 12+ years in technology leadership, clinical systems, business analysis, product ownership, clinical operations technology, or technology program leadership in biotech/pharma; or higher degree with 10+ years relevant experience.
- Experience leading technology solutions/enterprise platforms/portfolios including GxP systems.
- Experience implementing/optimizing Clinical Development capabilities (eTMF, CTMS and integrations).
- Experience delivering dashboards, predictive insights, automation, and decision-support tools.
- Experience supporting internal audits, regulatory inspections, inspection-readiness, CAPA, and evidence preparation for validated systems.
- Experience integrating clinical systems (CTMS, eTMF, EDC, safety, regulatory, site payments, study start-up, data warehouse, analytics/reporting).
Knowledge & Skills
- Strong stakeholder management, communication, and influencing across business, technical, quality, and vendor audiences.
- Ability to translate business needs into technology strategies/business cases/process improvements with measurable outcomes.
- Financial acumen (budget planning, investment prioritization, forecasting, value realization).
- Deep domain knowledge of clinical development and trial operations.
- Expertise delivering technology programs using Agile, product management, business analysis, business process analysis, and hybrid delivery.
- Deep understanding of SDLC, CSV, data integrity, audit trails, electronic records/e-signatures, and GxP/FDA/ICH system implementation practices.
- Ability to lead through ambiguity, influence without authority, develop talent, and deliver measurable impact.
Washington State Pay Range
$229,166 - $256,253 USD
Director, Clinical Development Systems (CDS) provides strategic and operational leadership of clinical systems for the Development function, including Trial Master File (TMF), Clinical Trial Management System (CTMS), reporting, AI-enabled dashboards, and KPI analytics. Partners cross-functionally (Development, IT, Quality, Procurement, Finance, external vendors) to deliver connected, inspection-ready, business-aligned capabilities and oversee a CDS team.
Responsibilities
- Serve as clinical systems leader; provide operational input on technology strategy, enterprise platforms, delivery options, and vendor solutions.
- Develop and maintain a multi-year systems roadmap aligned to business priorities, regulatory compliance, patient impact, and measurable value.
- Recommend and establish governance forums for prioritization, scope/risk management, adoption, and sustainment.
- Champion AI-enabled dashboards and advanced analytics for portfolio health, site performance, monitoring quality, TMF health, issue resolution, and operational risk.
- Manage business cases, budgets, vendor delivery, strategic sourcing inputs, and value realization.
- Lead TMF/CTMS implementation and modernization (process design, configuration, data migration, integration validation, training, adoption, change management).
- Deliver a connected clinical operations ecosystem from study start-up through closeout.
- Define trusted KPIs, data sources, quality standards, access controls, reporting needs, and scalable dashboards.
- Simplify manual tracking, reduce duplicate data entry, automate processes, and strengthen data integrity.
- Lead vendor/platform selection (RFPs, evaluations, business cases) and day-to-day vendor management.
- Ensure adherence to ICH-GCP, FDA, EMA, and global regulatory requirements; partner with Quality on validation, audits/inspections, corrective actions; drive data integrity.
- Maintain financial oversight; build and mentor the CDS team; support project and vendor teams; promote innovation, excellence, and continuous improvement.
Qualifications
- Bachelor’s degree (or equivalent) with 12+ years in technology leadership, clinical systems, business analysis, product ownership, clinical operations technology, or technology program leadership in biotech/pharma; or higher degree with 10+ years relevant experience.
- Experience leading technology solutions/enterprise platforms/portfolios including GxP systems.
- Experience implementing/optimizing Clinical Development capabilities (eTMF, CTMS and integrations).
- Experience delivering dashboards, predictive insights, automation, and decision-support tools.
- Experience supporting internal audits, regulatory inspections, inspection-readiness, CAPA, and evidence preparation for validated systems.
- Experience integrating clinical systems (CTMS, eTMF, EDC, safety, regulatory, site payments, study start-up, data warehouse, analytics/reporting).
Knowledge & Skills
- Strong stakeholder management, communication, and influencing across business, technical, quality, and vendor audiences.
- Ability to translate business needs into technology strategies/business cases/process improvements with measurable outcomes.
- Financial acumen (budget planning, investment prioritization, forecasting, value realization).
- Deep domain knowledge of clinical development and trial operations.
- Expertise delivering technology programs using Agile, product management, business analysis, business process analysis, and hybrid delivery.
- Deep understanding of SDLC, CSV, data integrity, audit trails, electronic records/e-signatures, and GxP/FDA/ICH system implementation practices.
- Ability to lead through ambiguity, influence without authority, develop talent, and deliver measurable impact.
Washington State Pay Range
$229,166 - $256,253 USD