Senior Director, Clinical Systems and Compliance

Nektar Therapeutics; California; On-site; USD 260,000 - 360,000; Full time

Job summary

Nektar Therapeutics seeks a Senior Director of Clinical Development Operations to lead strategy, oversight, and compliance of clinical systems and documentation for global trials. You will partner with IT to evaluate, implement, and optimize systems, while ensuring quality and inspection readiness across programs.

The role requires extensive GxP, GCP, ICH, and FDA regulation knowledge, with experience managing TMF and supervising the Clinical Documentation Group in a fast-paced environment.

Qualifications

• Bachelor's degree in a scientific or healthcare discipline.
• 13+ years in clinical development, operations, or quality with experience supporting systems like EDC, IRT, and eTMF.
• Extensive knowledge of GxP, GCP, ICH, and FDA regulations.

Responsibilities

• Lead strategy, oversight, and compliance of clinical systems and documentation processes for global trials.
• Partner with IT on system evaluation, implementation, and optimization.
• Manage quality, compliance, and inspection readiness activities; oversee TMF strategy.
• Supervise the Clinical Documentation Group.

Skills

Leadership

Cross-functional collaboration

GxP/GCP/ICH knowledge

Education

Bachelor's degree in a scientific or healthcare discipline

Tools

EDC systems

IRT systems

eTMF systems

Job description

Role: Senior Director of Clinical Development Operations, leading strategy, oversight, and compliance of clinical systems and documentation processes to support global clinical trials. Responsibilities include partnering with IT on system evaluation, implementation, and optimization; managing quality, compliance, and inspection readiness activities; providing strategic oversight of Trial Master File (TMF), and supervising the Clinical Documentation Group. Qualifications: Bachelor's in a scientific or healthcare discipline; 13+ years in clinical development, operations, or quality, with experience supporting systems like EDC, IRT, and eTMF; prior leadership preferred. HighValue: extensive GxP, GCP, ICH, FDA regulation knowledge; experience with clinical trial systems, audits, CAPA, and inspection readiness; cross-functional collaboration across clinical ops, IT, and quality; supporting global clinical trials. WorkSetup: not specified.