Strategic Lead, Clinical Systems & Compliance
Nektar Therapeutics
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Job summary
Nektar Therapeutics seeks a Senior Director of Clinical Development Operations to lead the strategy and governance of clinical systems, TMF programs, and quality initiatives. You will partner with IT and clinical leadership to ensure compliant, scalable systems across trials and vendors.
The role emphasizes inspection readiness, process optimization, and strong leadership of the Clinical Documentation Group, with a focus on regulatory adherence and data integrity.
Qualifications
- Bachelor's degree in clinical, biological, mathematical, nursing, or related field required.
- Advanced degree preferred.
- 13+ years of relevant experience in clinical development, operations, quality, or related areas.
- Experience implementing and supporting clinical systems like EDC, IRT, and eTMF.
Responsibilities
- Provide leadership for Clinical Development Operations systems strategy and governance.
- Partner with IT on system strategy, budgeting, forecasting, and roadmap planning.
- Oversee TMF management, documentation, and inspection readiness.
- Drive quality, compliance metrics, CAPA, and audit support.
- Lead the Clinical Documentation Group and manage vendor relationships.
- Foster cross-functional collaboration and process improvements.
Education
Tools
Job description
Nektar Therapeutics seeks a Senior Director of Clinical Development Operations to lead the strategy and governance of clinical systems, TMF programs, and quality initiatives. You will partner with IT and clinical leadership to ensure compliant, scalable systems across trials and vendors.
The role emphasizes inspection readiness, process optimization, and strong leadership of the Clinical Documentation Group, with a focus on regulatory adherence and data integrity.
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