Senior Director of Clinical Operations

Senior Director of Clinical Operations
Greater San Diego Area (Hybrid)
Salary: 234,000- 265,000

Our client is a cutting-edge NK cell therapy powerhouse. Being one of the only companies producing over the counter cell therapy compounds, this role offers a unique and innovative opportunity to a candidate looking to join the team as a Senior Director of Clinical Operations. What is really exciting about their drug discovery platform is that it is applicable to oncology, autoimmune, as well as other therapeutic areas. Their innovative platforms come from having one of the most highly touted leadership teams in the cell therapy space. Their CEO and CMO both worked at other cell therapy companies that have gained successful approvals before joining our client. With a robust pipeline; boasting several drugs in early phase trials, and one compound in phase three; this company is looking for an eager candidate willing to work in a fast-paced environment. This is a newly created position which allows for the right candidate to build and nurture a team at the forefront of cell therapy innovation.

Responsibilities:

1. Assess and deploy resources to execute corporate priorities
2. Implement clinical trial plans considering timelines, budgets, and resources
3. Develop and execute risk mitigation plans for compliant, timely, and cost-effective trials
4. Manage RFP process for CROs and vendors, including evaluation and selection
5. Oversee vendor agreements, ensuring adherence to scope, budgets, and timelines
6. Evaluate and select clinical sites, engaging with staff to meet enrollment goals
7. Drive operational excellence in clinical documentation and practices
8. Review invoices for accuracy against plans, budgets, and study progress
9. Prepare cost projections and budget forecasts with Finance Team
10. Maintain productive relationships with CROs, vendors, and clinical sites
11. Supervise Clinical Trial Managers and team members throughout study lifecycle
12. Ensure completion and application of all study-related documents
13. Train internal and external team members on protocols, SOPs, and regulations
14. Provide project management leadership for clinical and related disciplines
15. Oversee clinical logistics, including product distribution and sample management
16. Submit periodic reports on project status, costs, enrollments, and risks
17. Respond promptly to internal and external stakeholder queries
18. Collaborate on annual SOP reviews and process improvements

Qualifications:

1. Bachelor's in life sciences or equivalent; advanced degree preferred
2. 8+ years industry experience, including CRO management and clinical trial leadership

If you are interested in the Senior Director of Clinical Operations role, then please don't wait to apply.

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