Head of Business Enablement and Compliance

Head of Business Enablement and Compliance

Ipsen is a mid‑sized global biopharmaceutical company focused on transformative medicines in oncology, rare disease, and neuroscience. With nearly 100 years of development experience and global hubs in the U.S., France, and the U.K., we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are committed to advancing patients in 88 countries, fostering a culture of collaboration, excellence, and impact. At Ipsen, we empower individuals to grow and thrive alongside the company’s success.

The Head of Business Enablement and Compliance (BE&C) is a critical leadership role that establishes and optimises key capabilities for IPSEN. The incumbent builds a framework for internal business process ownership, manages key clinical systems (CTMS/TMF, etc.), and ensures training and compliance support the operational backbone of Clinical Development Operations and broader IPSEN.

This position reports to the Global Head of Clinical Development Operations (CDO) and leads a team of approximately six direct reports. The BE&C Head actively participates in the CDO Leadership Team, contributing cross‑functional expertise to shape CDO strategy and priorities, and partnering closely with R&D, Medical, and enabling functions to optimise capabilities for clinical trial planning, execution, close‑out, and site partnership/engagement.

The incumbent brings extensive experience with ICH‑GCP, regulatory requirements, and inspection readiness, championing new ways of working across R&D/Medical, identifying opportunities and best practices to elevate IPSEN’s clinical development activities to a best‑in‑class standard.

• Leadership
• Business Process Ownership
• Clinical Systems
• Training
• Compliance

• Drive Vision and Strategy
• Excellence in Execution
• Ensures Accountability
• Communicates Effectively
• Cultivate Innovation
• Instil Trust

• Sound financial acumen
• 10+ years’ experience in a pharmaceutical/biotech industry with a track record of transformational leadership in a global cross‑functional environment
• Experience in clinical development, clinical operations, quality, compliance, or related areas
• Deep understanding of the clinical trial landscape and commitment to innovation, creativity, and operational excellence
• Extensive knowledge of drug development processes, ICH‑GCP guidelines, 21 CFR Part 11, and major Health Authority regulations
• Experience in audit/inspection readiness, preparation, and conduct
• Proven ability to provide visionary and strategic leadership
• Experience in large‑scale organisational change‑management/implementation programs
• Proven influencer and change agent with superior project management capabilities, including planning, prioritisation, problem solving, and organisational skills, adept at managing multiple priorities in a dynamic environment, and an agile mindset
• Experience managing internal stakeholders and communicating across all levels of the organisation, up to ELT level
• 6+ years’ people/project management experience (e.g., leading project teams, operational teams, cross‑functional teams through operational change and transformation)
• Extensive knowledge of Good Clinical Practice and related global regulatory and compliance requirements for clinical studies
• Strong understanding of clinical systems (eTMF, CTMS, QMS) and business process design
• Effective leadership skills and proven ability to foster team productivity and cohesiveness in a changing environment