Description

You will lead the global clinical science strategy and study delivery from first-in-human through registration, driving decision-making for clinical programs. You'll oversee protocol development, data review, safety monitoring, and regulatory interactions, while collaborating with AI/ML teams to enhance clinical operations.

Requirements

• Advanced degree (MD, PhD, PharmD)
• 15+ years in pharmaceutical/biotech industry with startup experience
• Deep expertise in oncology or inflammation
• Proven success in leading programs from IND through late-stage development and regulatory filings
• Ability to interpret complex datasets and drive strategy in a matrixed environment

Responsibilities

• Lead global clinical science strategy, endpoint selection, and protocol development across trial lifecycle
• Spearhead end-to-end clinical data review and deliver evidence-based recommendations
• Accountable for safety monitoring and risk management strategies
• Author and review key clinical and regulatory documents
• Build and maintain strategic relationships with external partners and represent the organization in health authority interactions