Senior Medical Director, Clinical Safety

📋 Description

• Serve as the medical safety lead across BlueRock's clinical trial portfolio
• Lead SAE/SUSAR assessments and causality determinations
• Own safety signal detection and aggregate safety reviews
• Prepare safety sections for protocols, SAPs, CSRs, and DSURs
• Oversee safety vendor selection and PV operations
• Ensure global safety reporting compliance and inspection readiness

🎯 Requirements

• MD (or equivalent) required; active clinical training valued
• 5+ years pharma/biotech drug safety and pharmacovigilance experience
• Strong knowledge of FDA/EMA safety regulations; ICH E2 familiarity
• Hands-on SAE narratives, MedDRA coding, signal detection
• Lean, matrixed environment: builder mindset
• Excellent written and verbal communication; interest in cell/gene therapy a plus