Senior Director, Immunotherapy Clinical Operations

Dendreon Pharmaceuticals; Seal Beach (CA); On-site; USD 181,000 - 237,000; Full time

Job summary

Dendreon Pharmaceuticals in Seal Beach, CA seeks a Director of Clinical Operations to lead sponsor-driven studies, lifecycle management, and strategic execution for PROVENGE programs. You will manage study planning, budgets, timelines, and cross-functional teams to ensure quality and timely delivery.

Candidate must have extensive oncology/cellular therapy experience, 10+ years in clinical operations, and a track record of leading Sr.

Qualifications

• Minimum 10 years of progressive clinical research or Clinical Operations experience.
• Minimum 5 years leading clinical trials and cross-functional teams, with responsibility for CRO/vendor oversight, project management, contracts, budgets, and study delivery.
• Proven people-management experience, including direct leadership, coaching, development, and performance management of Sr. CRAs, CRAs, and/or other Clinical Operations professionals.
• Experience overseeing monitoring strategy, site management, TMF quality, inspection readiness, and resolution of operational or compliance issues.
• Oncology experience strongly preferred; cellular therapy/immunotherapy experience advantageous.

Responsibilities

• Lead end-to-end clinical study execution from feasibility and startup through database lock, closeout, and archival.
• Develop and manage study plans, timelines, budgets, resource strategies, enrollment forecasts, performance metrics, and risk-mitigation plans.
• Lead cross-functional study teams, establish governance and accountability, and communicate risks to senior leadership.
• Directly manage, coach, and develop Sr. CRAs, CRAs, and other Clinical Operations personnel; set objectives and evaluate performance.
• Ensure compliance with protocols, GCP/ICH, and maintain inspection-ready trial documentation and TMF quality.

Skills

Leadership

Budget management

Cross-functional teams

CRO oversight

Study management

TMF quality

GCP compliance

Oncology experience

Education

Bachelor’s degree in life sciences, nursing, pharmacy

Advanced scientific or clinical degree preferred

Tools

CTMS

eTMF

EDC

Microsoft Office

Job description

Dendreon Pharmaceuticals in Seal Beach, CA seeks a Director of Clinical Operations to lead sponsor-driven studies, lifecycle management, and strategic execution for PROVENGE programs. You will manage study planning, budgets, timelines, and cross-functional teams to ensure quality and timely delivery.

Candidate must have extensive oncology/cellular therapy experience, 10+ years in clinical operations, and a track record of leading Sr.