Head of Clinical Development

Responsibilities

• You will lead the clinical development strategy for a rare disease program moving into registrational-stage studies, with full ownership of clinical direction, decision-making, and execution
• As the Head of Clinical Development, you will be senior clinical voice across cross-functional teams to drive aligned practical development plans.
• Own global regulatory interactions and clinical positioning with health authorities (e.g. FDA, EMA, MHRA), including clinical input into briefing documents and agency meetings
• Oversee clinical safety and pharmacovigilance activities in a hands-on way, ensuring patient safety, data integrity, and clear clinical governance
• Translate complex clinical and scientific data into clear strategy for internal teams, leadership, and external partners
• You will be responsible for building and scaling a high-performing clinical development function as the program transitions into later-stage and registrational execution

• MD or DO with strong experience in rare disease drug development, ideally in genetically driven pediatric/adolescent conditions
• 8–12+ years in clinical development roles with direct ownership of late-stage and registrational programs
• Proven experience leading global regulatory interactions (FDA, EMA, MHRA; additional global agency exposure a plus)
• Strong command of clinical data and statistics, with the ability to interpret complex datasets and guide development decisions
• Track record of working in lean, fast-moving biotech environments where leaders are hands-on and execution-focused