Director, Clinical Development Systems
$229,166–$256,253 year
On-siteBothell, Washington, United States
Job Summary
Lead the Development function's clinical systems strategy, roadmap, and implementation plans for Trial Master File (TMF), Clinical Trial Management System (CTMS), and AI-enabled dashboards. Partner with Development, IT, Quality, and external vendors to establish connected, inspection-ready capabilities spanning study start-up through closeout. Manage business cases, budgets, and vendor delivery while championing automation, data integrity, and KPI analytics for portfolio health. Ensure adherence to ICH-GCP, FDA, and EMA requirements through system validation and audit readiness. Lead a high-performing team of Business Analysts and Systems Administrators, driving operational excellence and continuous improvement across the clinical development portfolio.
Required Qualifications
- Bachelor's degree or equivalent experience
- 12+ years in technology leadership, clinical systems, business analysis, product ownership, clinical operations technology, or technology program leadership within the biotech/pharma industry
- Experience leading technology solutions, enterprise platforms, or technology portfolios including GxP systems
- Experience implementing and optimizing Clinical Development capabilities, particularly eTMF, CTMS implementations and related integrations
- Experience delivering dashboards, predictive insights, automation, and decision-support tools
- Experience supporting internal audits, regulatory inspections, inspection-readiness activities, CAPA, and evidence preparation for validated clinical systems
- Experience integrating clinical systems such as CTMS, eTMF, EDC, safety, regulatory, site payments, study start-up, data warehouse, analytics, or reporting platforms
- Strong stakeholder management, communication, and influencing skills across business, technical, quality, and vendor audiences, including senior leadership
- Demonstrated ability to translate business needs into technology strategies, business cases, process improvements, and measurable outcomes
- Financial acumen for technology portfolio leadership (budget planning, investment prioritization, forecasting, and value realization)
- High degree of domain knowledge of clinical development and clinical trial operations
- Expertise in delivering technology programs using Agile, product management, business analysis, business process analysis, and hybrid delivery methodologies
- Deep understanding of system development life cycle, computer system validation, data integrity, audit trails, electronic records/electronic signatures, and GxP, FDA, ICH regulated system implementation practices
- Demonstrated ability to lead through ambiguity, influence without direct authority, develop talent, and deliver measurable business impact with a high degree of professionalism, adaptability, and accountability
Desired Qualifications
- Higher degree with 10+ years of relevant experience
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