Senior Director of Clinical Operations
Greater San Diego Area (Hybrid)
Salary: 234,000- 265,000 + 30% bonus + equity
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 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.
The Senior Director of Clinical Operations will be responsible for:
- Assess and deploy resources to execute corporate priorities
- Implement clinical trial plans considering time lines, budgets, and resources
- Develop and execute risk mitigation plans for compliant, timely, and cost-effective trials
- Manage RFP process for CROs and vendors, including evaluation and selection
- Oversee vendor agreements, ensuring adherence to scope, budgets, and time lines
- Evaluate and select clinical sites, engaging with staff to meet enrollment goals
- Drive operational excellence in clinical documentation and practices
- Review invoices for accuracy against plans, budgets, and study progress
- Prepare cost projections and budget forecasts with Finance Team
- Maintain productive relationships with CROs, vendors, and clinical sites
- Supervise Clinical Trial Managers and team members throughout study life cycle
- Ensure completion and application of all study-related documents
- Train internal and external team members on protocols, SOPs, and regulations
- Provide project management leadership for clinical and related disciplines
- Oversee clinical logistics, including product distribution and sample management
- Submit periodic reports on project status, costs, enrollments, and risks
- Respond promptly to internal and external stakeholder queries
- Collaborate on annual SOP reviews and process improvements
The Senior Director of Clinical Operations should have the following qualifications:
- Bachelor's in life sciences or equivalent; advanced degree preferred
- 8+ years industry experience, including CRO management and clinical trial leadership
- Knowledge of ICH/GCP, FDA/EMA regulations, and quality standards; international study experience preferred
- Experience with clinical SOPs, CSRs, INDs, and other regulatory documents
- Strong communication skills; ability to work with senior management
- Proven collaboration with stakeholders, collaborators, and clinical sites
- Values creativity, passion, and independent thinking
Benefits:
- 5 weeks PTO
- Free access to company gym
- Catered Lunches
If you are interested in the Senior Director of Clinical Operations role, then please don't wait to apply.
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