Senior Director of Clinical Operations
Lindus Health
Lindus Health seeks a Senior Director of Clinical Operations to lead clinical delivery of an in-licensed therapeutic asset through trial completion, while shaping operational standards across a portfolio of early-stage drug development programs.
Responsibilities
- Own clinical, regulatory, and quality execution of assigned asset trial from startup through closeout
- Make real-time clinical, safety, and quality decisions in collaboration with Clinical Program Manager
- Contribute to portfolio-wide SOP development, quality standards, and operational systems
- Provide senior guidance to other trial teams while respecting their decision-making authority
- Partner with Chief Medical Officer, Quality Director, and cross-functional stakeholders on trial governance
Requirements
- 15+ years hands-on clinical operations experience across multiple Phase 2 trials
- Demonstrated expertise in complex neurology trials, preferably Parkinson's disease
- Track record of senior-level review and approval of trial-critical documents
- Experience designing SOPs and processes at portfolio or functional level
- Risk-based clinical oversight approach with independent safety and quality judgment
- Multi-jurisdictional regulatory experience; FDA experience preferred
- Demonstrated influence on trial systems implementation (EDC, CTMS, eTMF)
Vacancy posted 10 days ago
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