Senior Director of Clinical Operations

Senior Director of Clinical OperationsGreater San Diego Area (Hybrid)Salary : 234,000- 265,000 + 30% bonus + equityOur 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 prioritiesImplement clinical trial plans considering time lines, budgets, and resourcesDevelop and execute risk mitigation plans for compliant, timely, and cost-effective trialsManage RFP process for CROs and vendors, including evaluation and selectionOversee vendor agreements, ensuring adherence to scope, budgets, and time linesEvaluate and select clinical sites, engaging with staff to meet enrollment goalsDrive operational excellence in clinical documentation and practicesReview invoices for accuracy against plans, budgets, and study progressPrepare cost projections and budget forecasts with Finance TeamMaintain productive relationships with CROs, vendors, and clinical sitesSupervise Clinical Trial Managers and team members throughout study life cycleEnsure completion and application of all study-related documentsTrain internal and external team members on protocols, SOPs, and regulationsProvide project management leadership for clinical and related disciplinesOversee clinical logistics, including product distribution and sample managementSubmit periodic reports on project status, costs, enrollments, and risksRespond promptly to internal and external stakeholder queriesCollaborate on annual SOP reviews and process improvementsThe Senior Director of Clinical Operations should have the following qualifications:Bachelor's in life sciences or equivalent; advanced degree preferred8+ years industry experience, including CRO management and clinical trial leadershipKnowledge of ICH/GCP, FDA/EMA regulations, and quality standards; international study experience preferredExperience with clinical SOPs, CSRs, INDs, and other regulatory documentsStrong communication skills; ability to work with senior managementProven collaboration with stakeholders, collaborators, and clinical sitesValues creativity, passion, and independent thinkingBenefits:5 weeks PTOFree access to company gymCatered LunchesIf you are interested in the Senior Director of Clinical Operations role, then please don't wait to apply.

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