Head of Business Enablement and Compliance in London

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 endeavour 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. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company's success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

Summary & Purpose of the Position

The Head of Business Enablement and Compliance (BE&C) will be a critical leadership role whose responsibilities 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. The individual will be an active member of the CDO Leadership Team and will contribute their cross‐functional expertise to support in shaping CDO Strategy and priorities. They 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. The individual will bring extensive experience in ICH‐GCP and regulatory requirements to shape IPSEN's strategies for business process, training IPSEN staff and vendors whilst ensuring a culture and practice of inspection readiness. They will champion these new ways of working across R&D/Medical, identifying opportunities and best practices to elevate Ipsen clinical development activities to best‐in‐class standard.

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 consistency of approach and alignment on standard practices across functions and teams, including GMA, where applicable.
  • Establishes a clear Business Process Ownership framework providing clarity and transparency on how SOPs are organized enabling their effective use.
  • Ensure SOPs are fit for purpose and capture applicable corrective actions from audit findings.
  • Outline process for review/approval of SOPs.
  • Outline the process for implementation of these SOPs and partners.
• 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 and the broader digital ecosystem.
  • 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, ensuring stability, scalability, and long‐term digital enablement for clinical teams.
  • Ensure effective partnership across Clinical Operations, Digital/Data functions, Quality, and IT by empowering teams to translate business needs into system capabilities, adoption strategies, and user experience improvements.
  • Drive continuous improvement and digital transformation by guiding the teams to identify AI/innovation opportunities, enhance workflows and oversight, and strengthen Ipsen's clinical systems ecosystem.
• Training
  • Oversee the design, governance, and continuous improvement of global role‐based training curricula, onboarding programs, and competency frameworks across clinical and enabling functions.
  • Ensure LMS and training processes meet compliance requirements, including GxP, inspection readiness, and auditable documentation standards.
  • Lead the development and execution of training strategies that support new systems, processes, and organizational changes, driving high adoption and sustained performance improvements.
  • Partner with functional leaders e.g. Quality and HR Learning teams to ensure training content is accurate, standardized, current, and effectively delivered across global teams.
  • Monitor training performance through metrics, dashboards, and compliance indicators, using insights to guide prioritization, resource allocation, and continuous capability enhancements.
  • Build and mentor a high‐performing Training team, fostering innovation, collaboration, and a culture of continuous learning aligned with the Ipsen Way of Being.
• Compliance
  • Directs and oversees the Compliance team, ensuring robust monitoring of compliance risks and that mitigation and remediation plans are effectively prioritized, resourced, and delivered.
  • Create and oversee a framework for QC checks, compliance monitoring, and TMF/training documentation reviews, ensuring risk signals are escalated appropriately and addressed with timely, high‐quality corrective actions.
  • Guide and support the team in preparation for audits, inspections, and Quality Reviews, ensuring cross‐functional alignment with clinical operations, quality, and regulatory partners.
  • Ensure strong CAPA governance by reviewing root‐cause analyses, validating CAPA effectiveness, and fostering a consistent, risk‐based approach across countries and studies.
  • Oversee and partner (e.g. CROs) the team's assessment of local regulatory intelligence and procedural document updates, ensuring that changes are translated into clear operational guidance and incorporated into quality systems.
  • Ensure effective onboarding and handover process for CDO staff and contractors.
  • Enable a centralized system for storage and rapid retrieval of job descriptions, training files and CVs as required under ICH‐GCP standards.
  • Include mechanism for periodic review of such documents for audit/inspection readiness.
  • Monitor emerging compliance concerns, review policy and procedural deviations, and drive trending across CDO audit/inspection root cause analyses for lessons learned and review meetings for operational adjustments.

Behavioural Competencies Required

• Drive Vision and Strategy – vision for future, compelling strategy motivates others.
• Excellence in Execution – consistently achieve results, prioritize effectively, commit to best practice sharing.
• Accountability – hold self and others accountable, clarify responsibilities, seek stakeholder views.
• Communicate Effectively – deliver clear, transparent messages, respect diverse perspectives.
• Innovate – create new ways, question status‐quo, integrate perspectives.
• Instil Trust – honesty, integrity, authenticity, approachability.

Knowledge & Experience (essential)

• 10+ years in pharmaceutical/biotech or related industry with 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.
• Visionary and strategic leadership; large‐scale organisational change management.
• Proven influencer and change agent with strong project management.
• Capacity to manage multiple priorities in a dynamic, agile environment.
• Experience communicating across all levels including ELT.
• 6+ years people/project management experience.
• Strong understanding of clinical systems (eTMF, CTMS, QMS, etc.) and business process design.
• Effective leadership; foster team productivity and cohesiveness.
• Sound financial acumen.

Education / Certifications (essential)

• Minimum bachelor's degree in a scientific discipline or general management.

Education / Certifications (preferred)

• Advanced degree (Masters, MBA, MD, PhD).

Language(s) (essential)

• English

Equal Opportunity Employer

We are 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. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application.

Benefits & Work Culture

At Ipsen, each employee makes a real impact. Our teams are passionate about what they do because they care about making a difference in patients' lives. We invest in our employees to support life‐changing projects that create positive impact for patients and society.