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The company focuses on early-phase oncology drug development and is preparing for its first asset.
- Industry: Biotechnology, Oncology
- Focus: AI-driven therapeutic development
- Stage: Early phase, first-in-human studies
- Work Environment: Hybrid (a few days in office)
Role: Senior Clinical Operations Lead
(Equivalent to Head of Clinical Operations, Clinical Trial Manager, or Clinical Study Manager)
Responsibilities:
- Leading clinical trial operations, particularly early-phase (Phase 1) oncology studies
- Setting up and executing first-in-human studies
- By setting up I mean being comfortable with being the first clinical hire and building the function from the ground up.
- Vendor management, hospital site setup, and regulatory/ethics submissions
- Providing strategic guidance to the C-suite on clinical trial execution
- Taking the first clinical asset into trials, targeting a CTA submission by February next year
- Working hands-on in a startup biotech environment with minimal support
Must-Have Qualities:
- Experience: 8+ years in oncology clinical trials, specifically early-phase studies
- Hands-On Leadership: Ability to lead clinical operations independently, particularly in a startup setting
- Direct Sponsor Experience: Must have worked directly for a sponsor (not just CRO experience)
- Startup Mindset: Comfortable being the first clinical hire and building the function from the ground up
- Regulatory Knowledge: Familiarity with ethics submissions, vendor management, and site setup
- Communication & Influence: Ability to guide and inform senior leadership on clinical strategy
