Lead Clinical Development Director, Rare (Remote)

Overview

In this role you lead clinical development efforts for rare disease programs within Ipsen, guiding strategy and execution from lead compound to registration and launch. You will contribute clinical and scientific expertise to CDP and trial documentation, align cross-functionally to ensure program success, and interact with external experts and regulators. You’ll shape study outcomes, monitor budgets and timelines, and represent Ipsen’s medical voice in oncology and rare disease. This is a high-impact position with global collaboration and a focus on transformation and data quality.

Responsibilities

• Provide clinical, scientific and strategic expertise across CDP and trial documentation (IBs, synopses, protocols, summaries, CSR)
• Ensure CDP execution and cross-functional alignment to support program goals
• Make final clinical decisions for study teams and enable clinical operations to meet objectives
• Address complex issues requiring deep therapeutic area knowledge
• Develop and review key documents (TPP, IDP, KPIs) and manage budgets/schedules
• Interact with KOLs, investigators, and external experts to advance programs
• Support clinical trial conduct and interfacing with medical CROs
• Contribute to clinical monitoring, data integrity and interpretation
• Contribute to scientific communications (abstracts, articles, presentations)
• Establish and maintain relationships with external medical experts and thought leaders
• External to TA: liaise with pre-clinical/early development and industry intelligence teams
• Provide medical expertise to support pre-clinical programs and potential new assets
• Collaborate with External Innovation and BD for due diligence and program development
• Comply with SOPs, GCP and regulatory guidelines
• Maintain external professional network and ongoing scientific knowledge
• Support transformation and high-performance culture within R&D

Key requirements

• Negotiation with customers or management
• Influencing senior leaders
• Cross-functional collaboration
• Clinical development leadership
• CDP and regulatory document preparation (IBs, protocols, CSR)
• Clinical monitoring and data interpretation

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