Vice President, Clinical Operations

A typical mandate

The company develops small molecules that modulate neuronal excitability, with a lead program in focal epilepsy. Encouraging Phase 2a results have led to a global Phase 2b across North America and Europe. Operations has relied on a CRO and a few contractors, and now needs an internal leader.

What the role owns

• Lead CRO selection and contracting for the Phase 2b, and own vendor oversight end to end
• Hire clinical trial managers and site relationship leads to build an in-house team
• Set study budgets, enrollment plans and risk-based quality management consistent with ICH E6(R3)
• Develop site strategy with epilepsy centers in the US and Europe
• Establish SOPs, TMF practices and inspection readiness from an early-stage baseline
• Report study progress and risks to the CMO and the board

What great candidates bring

• Bachelor's degree in life sciences; advanced degree preferred
• 12+ years in clinical operations, with at least 4 leading a function or large program
• Delivery of global Phase 2 or Phase 3 studies, ideally in CNS
• Strong CRO governance experience across full-service and functional models
• Working command of ICH E6(R3), risk-based monitoring and TMF requirements
• Comfort building processes in a company still writing its first SOPs

Why it matters

• First senior clinical operations hire, reporting to the CMO
• Meaningful equity at Series B
• Room to design the function, its systems and its team
• Hybrid schedule