Senior Director, Clinical Systems and Compliance

Senior Director, Clinical Systems and Compliance

Clinical Development Operations

Position Summary

This leadership role within Clinical Development Operations (ClinDevOps) is responsible for the strategy, oversight, implementation, and compliance of clinical systems and processes that support clinical trials. The position partners closely with IT and Clinical Development Operations leadership to ensure systems are evaluated, implemented, maintained, and operated in accordance with applicable regulations, industry standards, and Nektar SOPs.

The Senior Director serves as the Veeva eTMF Business Administrator and provides strategic leadership for Trial Master File (TMF) management, clinical compliance activities, quality management initiatives, and clinical documentation operations. This role also oversees the Clinical Documentation Group and supports inspection readiness across clinical development programs.

This role contributes to and supports the company's research and development efforts to create innovative therapeutics that address unmet medical needs.

Key Responsibilities

Clinical Systems Leadership

- Serve as the business partner to IT for all Clinical Development Operations systems.

- Partner with IT on system strategy, implementation, prioritization, forecasting, budgeting, and roadmap planning.

- Evaluate, select, implement, and optimize clinical trial systems to improve operational effectiveness and compliance.

- Provide business owner oversight for system validation, implementation projects, change control, and vendor-supported systems.

- Ensure training and adoption of clinical systems across internal and external teams.

- Maintain expertise in clinical trial technologies, including IRT, EDC, Veeva eTMF, and related platforms.

- Serve as System Business Owner and Veeva eTMF Business Administrator as required.

Quality and Compliance Oversight

- Develop and execute quality and compliance strategies across Clinical Development Operations.

- Lead compliance initiatives and quality management activities.

- Ensure Quality Events are appropriately investigated, documented, and resolved.

- Develop compliance metrics, dashboards, and oversight tools.

- Support internal audits, regulatory inspections, and CAPA management.

- Drive continuous process improvements and maintain SOPs supporting systems and compliance activities.

- Identify and mitigate operational and compliance risks through ongoing oversight and trend analysis.

TMF and Documentation Management

- Provide strategic oversight of the Trial Master File (TMF) throughout the study lifecycle.

- Ensure TMF quality reviews, filing standards, and inspection readiness.

- Oversee TMF processes, vendor management, document retention, archival activities, and decommissioning.

- Lead and manage the Clinical Documentation Group.

Leadership and Collaboration

- Collaborate cross-functionally to drive alignment and support across development functions.

- Participate in organizational planning, project evaluation, and process improvement initiatives.

- Hire, develop, coach, and manage direct reports as applicable.

- Foster a culture of quality, compliance, accountability, and operational excellence.

Qualifications

Education

- Bachelor's degree in clinical, biological, mathematical, nursing, or related scientific discipline required.

- Advanced degree preferred.

Experience

- 13+ years of relevant experience within clinical development, clinical operations, quality, compliance, or related functions.

- Experience implementing and supporting clinical systems such as EDC, IRT, and eTMF platforms.

- Experience partnering with IT and cross-functional stakeholders on system evaluation and implementation.

- Experience managing clinical quality and compliance programs in a regulated environment.

- Experience supporting inspections, audits, Quality Events, and CAPA activities.

- Previous people leadership experience preferred.

Knowledge,