Title: Head of Business Enablement and Compliance
Company: Ipsen Biopharm Ltd

About Ipsen
Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with 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 focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact.

Job Description
Division / Function: Clinical Development Operations, Research and Development
Manager’s Job Title: Head of Clinical Development Operations
Location: US, UK or France

Summary & Purpose of the Position
The Head of Business Enablement and Compliance (BE&C) will be a critical leadership role whose responsibilities will include establishing and optimizing, through continuous improvement, key capabilities for IPSEN focusing on building a framework for internal business processes ownership, business management of key Clinical systems (CTMS/TMF etc.), training and Compliance ensuring these capabilities effectively support the operational backbone of Clinical Development Operations and broader IPSEN.

This BE&C Head reports to the Global Head of Clinical Development Operations (CDO) and leads a team of ~6 direct reports. This individual will be an active member of the CDO Leadership Team and will contribute their cross functional expertise to support in the shaping of CDO Strategy and priorities. In this role the individual will partner closely with the different R&D, Medical and enabling functions (e.g. IT, Quality etc.) to shape and optimise these capabilities in support of clinical trial planning, execution, close out and site partnership/engagement.

Main Responsibilities & Technical Competencies
Leadership

• Provide strategic leadership to a multi‑functional team, setting vision, priorities, and expectations that enable high‑quality delivery across compliance, training, systems support, and business process ownership.
• Coach, mentor, and develop team members to build deep functional expertise, foster a culture of accountability, and support long‑term talent development within Clinical Development Operations.
• Create an inclusive, collaborative, and high‑performing team environment aligned with the Ipsen Way of Being, encouraging innovation, continuous improvement, and shared learning.
• Serve as an active and influential member of the CDO senior leadership team, contributing to organizational strategy, portfolio execution, and cross‑functional decision‑making.
• Build strong partnerships with senior leaders across Clinical Development Operations, Quality, Medical, Regulatory, and Digital/Data organizations to ensure alignment, transparency, and effective cross‑functional delivery.
• Lead/sponsor change initiatives that strengthen operational excellence and support the successful adoption of new processes, systems, and ways of working across the global organization.

Business Process Ownership

• Responsible for IPSEN’s Clinical Development SOP strategy in collaboration with the Global Quality team.
• Ensures a clear plan for process management in-line with IPSENs desire to move toward Functional Service Provision.
• Establishes a clear Business Process Ownership framework providing clarity and transparency on how SOPs are organized enabling their effective use.
• Ensure that the SOPs are fit for purpose and captures applicable corrective actions from the audits findings.
• Outlines process for review/approval of the SOPs.

Clinical Systems

• Provide strategic oversight and direction to the clinical system team’s (CTMS/TMF etc.), ensuring clear vision, roadmap, and integrations align with enterprise clinical operations strategy.
• Establish and lead governance frameworks that guide cross‑system integration, data stewardship, quality, and compliance, ensuring sustained alignment with GxP and internal standards.
• Oversee prioritization, resource allocation, and performance management for clinical platform evolution.
• Drive continuous improvement and digital transformation by guiding the teams to identify AI/innovation opportunities.

Training

• Oversee the design, governance, and continuous improvement of global role‑based training curricula, onboarding programs, and competency frameworks.
• Ensure Learning Management Systems (LMS) and training processes meet compliance requirements, including GxP and inspection readiness.
• Partner with functional leaders e.g. Quality and HR Learning teams to ensure training content is accurate and standardized.

Compliance

• Directs and oversees the Compliance team, ensuring robust monitoring of compliance risks and that mitigation and remediation plans are effectively prioritized.
• Create and oversee a framework for QC checks, compliance monitoring, and TMF/training documentation reviews.
• Guide and support the team in preparation for audits, inspections, and Quality Reviews.
• Ensure strong CAPA governance by reviewing root‑cause analyses and validating CAPA effectiveness.
• Enables a centralized system for storage and rapid retrieval of job descriptions, training files and CVs as required under ICH-GCP standards.

Knowledge & Experience

• 10+ years’ experience within pharmaceutical/biotech or related industry with track record of transformational leadership.
• Experience in clinical development, clinical operations, quality, compliance, or related areas.
• 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.
• 6+ years’ people/project management experience.
• Strong understanding of clinical systems (eTMF, CTMS, QMS, etc.) and business process design.
• A minimum of a bachelor’s degree in a scientific discipline or general management is required.

Ipsen is committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities.