Director, Clinical Development Systems
Immunome, Inc.
August 29, 2026
Remote friendly (Bothell, WA)
United States
IT
Position Overview:
The Director, Clinical Development Systems (CDS) provides strategic and operational leadership of clinical systems, advancing the Development function’s systems strategy, roadmap, and implementation plans, including Trial Master File (TMF), Clinical Trial Management System (CTMS), reporting, AI-enabled dashboards, and KPI analytics.
Responsibilities:
- Serve as a 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 clinical systems programs (prioritization, scope/risk management, adoption, sustainment).
- Champion AI-enabled dashboards and advanced analytics (portfolio health, site performance, monitoring quality, TMF health, issue resolution, operational risk).
- Manage business cases, budgets, vendor delivery, strategic sourcing inputs, and value realization.
- Lead cross-functional TMF/CTMS implementation and modernization (process design, configuration, data migration, integration validation, training, adoption, change management).
- Deliver a connected clinical operations ecosystem across study start-up to closeout.
- Partner with data/analytics leaders to define KPIs, data sources, quality standards, access controls, reporting needs, and scalable dashboards.
- Identify opportunities to simplify tracking, reduce duplicate data entry, automate processes, and strengthen data integrity.
- Lead vendor/platform selection (RFPs, evaluations, business case development) and oversee vendor management.
- Ensure adherence to ICH-GCP, FDA, EMA, and global regulatory requirements; partner with Quality on validation, audits/inspections, and CAPA.
- Maintain oversight of CDS budgets and resource planning; build and mentor a CDS team.
Qualifications:
- Bachelor’s degree or equivalent experience; 12+ years in technology leadership/clinical systems/business analysis/product ownership/clinical operations technology/technology program leadership in biotech/pharma (or higher degree with 10+ years).
- Experience leading GxP enterprise platforms/technology portfolios.
- Experience implementing/optimizing eTMF and CTMS and related integrations.
- Experience delivering dashboards, predictive insights, automation, decision-support tools.
- Experience with internal audits, regulatory inspections, CAPA, and evidence preparation for validated clinical systems.
- Experience integrating CTMS, eTMF, EDC, safety, regulatory, site payments, study start-up, data warehouse, analytics, or reporting platforms.
Knowledge/Skills:
- Strong stakeholder management and communication; ability to translate business needs into technology strategy and measurable outcomes.
- Financial acumen for technology portfolio leadership.
- Deep clinical development/trial operations domain knowledge.
- Expertise delivering technology programs using Agile/product management/business analysis/hybrid methods.
- 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.
Pay range (if provided as part of role): $229,166–$256,253 USD.
The Director, Clinical Development Systems (CDS) provides strategic and operational leadership of clinical systems, advancing the Development function’s systems strategy, roadmap, and implementation plans, including Trial Master File (TMF), Clinical Trial Management System (CTMS), reporting, AI-enabled dashboards, and KPI analytics.
Responsibilities:
- Serve as a 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 clinical systems programs (prioritization, scope/risk management, adoption, sustainment).
- Champion AI-enabled dashboards and advanced analytics (portfolio health, site performance, monitoring quality, TMF health, issue resolution, operational risk).
- Manage business cases, budgets, vendor delivery, strategic sourcing inputs, and value realization.
- Lead cross-functional TMF/CTMS implementation and modernization (process design, configuration, data migration, integration validation, training, adoption, change management).
- Deliver a connected clinical operations ecosystem across study start-up to closeout.
- Partner with data/analytics leaders to define KPIs, data sources, quality standards, access controls, reporting needs, and scalable dashboards.
- Identify opportunities to simplify tracking, reduce duplicate data entry, automate processes, and strengthen data integrity.
- Lead vendor/platform selection (RFPs, evaluations, business case development) and oversee vendor management.
- Ensure adherence to ICH-GCP, FDA, EMA, and global regulatory requirements; partner with Quality on validation, audits/inspections, and CAPA.
- Maintain oversight of CDS budgets and resource planning; build and mentor a CDS team.
Qualifications:
- Bachelor’s degree or equivalent experience; 12+ years in technology leadership/clinical systems/business analysis/product ownership/clinical operations technology/technology program leadership in biotech/pharma (or higher degree with 10+ years).
- Experience leading GxP enterprise platforms/technology portfolios.
- Experience implementing/optimizing eTMF and CTMS and related integrations.
- Experience delivering dashboards, predictive insights, automation, decision-support tools.
- Experience with internal audits, regulatory inspections, CAPA, and evidence preparation for validated clinical systems.
- Experience integrating CTMS, eTMF, EDC, safety, regulatory, site payments, study start-up, data warehouse, analytics, or reporting platforms.
Knowledge/Skills:
- Strong stakeholder management and communication; ability to translate business needs into technology strategy and measurable outcomes.
- Financial acumen for technology portfolio leadership.
- Deep clinical development/trial operations domain knowledge.
- Expertise delivering technology programs using Agile/product management/business analysis/hybrid methods.
- 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.
Pay range (if provided as part of role): $229,166–$256,253 USD.