Head of Business Enablement and Compliance London

The Head of Business Enablement and Compliance (BE&C) will be a critical leadership role focused on establishing and optimizing key capabilities for IPSEN. This includes 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 approximately six direct reports. The role actively contributes to CDO Leadership Team strategy and priorities and partners closely with R&D, Medical, IT, Quality, and other enabling functions to shape and optimise 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, and inspection readiness, championing new ways of working across the organization.

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 accountability, and support long‑term talent development.
  • Create an inclusive, collaborative, high‑performing team environment aligned with the Ipsen Way of Being.
  • Serve as an influential member of the CDO senior leadership team, contributing to strategy and cross‑functional decision‑making.
  • Build strong partnerships with senior leaders across Clinical Development Operations, Quality, Medical, Regulatory, and Digital/Data organizations.
  • Lead/sponsor change initiatives that strengthen operational excellence and support adoption of new processes, systems, and ways of working.
• Business Process Ownership
  • Responsible for IPSEN’s Clinical Development SOP strategy in collaboration with the Global Quality team.
  • Ensure a clear plan for process management aligned with IPSEN’s move toward Functional Service Provision.
  • Establish a clear Business Process Ownership framework providing clarity on SOP organization and usage.
  • Ensure SOPs are fit for purpose and capture corrective actions from audit findings.
  • Outline processes for SOP review/approval and implementation.
• Clinical Systems
  • Provide strategic oversight and guidance to the clinical system team (CTMS/TMF etc.) ensuring a clear vision, roadmap, and integrations aligned with enterprise clinical operations and the digital ecosystem.
  • Establish governance frameworks guiding cross‑system integration, data stewardship, quality, and compliance.
  • Oversee prioritization, resource allocation, and performance management for clinical platform evolution.
  • Ensure effective partnership across Clinical Operations, Digital/Data, Quality, and IT to translate business needs into system capabilities, adoption, and user experience improvements.
  • Drive continuous improvement and digital transformation by guiding teams to identify AI/innovation opportunities and enhance workflows.
• Training
  • Oversee the design and continuous improvement of global role‑based training curricula, onboarding programs, and competency frameworks.
  • 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.
  • Partner with functional leaders to ensure training content is accurate, standardized, and effectively delivered.
  • Monitor training performance through metrics, dashboards, and compliance indicators.
  • Build and mentor a high‑performing Training team aligned with the Ipsen Way of Being.
• Compliance
  • Direct and oversee the Compliance team, ensuring robust monitoring of compliance risks and effective prioritization.
  • Create and oversee a framework for QC checks, compliance monitoring, and TMF/training documentation reviews.
  • Guide the team in preparation for audits, inspections, and Quality Reviews.
  • Ensure strong CAPA governance by reviewing root‑cause analyses and validating CAPA effectiveness.
  • Oversee and partner with CROs on local regulatory intelligence, procedural document updates, and operational guidance.
  • Ensure effective onboarding and handover processes for CDO staff and contractors.
  • Enable a centralized system for storing and retrieving job descriptions, training files, and CVs in line with ICH‑GCP standards.
  • Monitor emerging compliance concerns and review policy and procedural deviations impacting CDO objectives.
  • Enable mechanism for trending audit/inspection root cause analyses and drive review meetings for operational adjustments.

Behavioural Competencies

• Drive Vision and Strategy
  • Translate future possibilities into breakthrough strategies and motivate others.
• Excellence in Execution
  • Plan, prioritize, and execute work to meet commitments aligned with organizational goals.
  • Establish clarity on goals, accountabilities, timelines, and next steps.
  • Use clear KPIs and promote single points of accountability.
  • Facilitate best practice sharing and setting.
• Ensures Accountability
  • Hold self and others accountable to meet commitments.
  • Ensure single accountable referents per task or project outcome.
  • Build an environment where clarification is sought when accountabilities are unclear.
  • Consult stakeholders and ensure decisions are made by consensus.
  • Take personal accountability for decisions, actions, successes, and failures.
  • Follow through on commitments and ensure others do the same.
• Communicates Effectively
  • Develop and deliver multi‑mode communications for diverse audiences.
  • Ask open questions, dig deeper, and show respect for different perspectives.
  • Communicate transparently while maintaining respectful tone.
  • Build clear and concise messages.
  • Demonstrate gravitas.
• Cultivate Innovation
  • Question status‑quo and adopt new approaches.
  • Bring vision, ideas, and actions.
  • Think outside the box and reframe problems.
  • Encourage and integrate different perspectives.
• Instils Trust
  • Gain confidence and trust through honesty, integrity, and authenticity.
  • Display approachability and humility, role‑model learning behaviours.

Knowledge & Experience

• 10+ years experience within pharmaceutical/biotech or related industry with transformational leadership across a global cross‑functional environment.
• Experience in clinical development, operations, quality, compliance, or related areas.
• Deep understanding of the clinical trial landscape and commitment to innovation and operational excellence.
• Extensive knowledge of ICH‑GCP, 21 CFR Part 11, and major Health Authority regulations.
• Experience in audit/inspection readiness, preparation, and conduct.
• Visionary and strategic leadership skills.
• Experience in large‑scale organisational change management/implementation programs.
• Proven influencer and change agent with project management excellence.
• Experience in managing internal stakeholders and communicating across all levels, including ELT.
• 6+ years people/project management experience (e.g., leading teams through operational change and transformation).
• Extensive knowledge of Good Clinical Practice and related global regulatory requirements.
• Strong understanding of clinical systems (eTMF, CTMS, QMS, etc.) and business process design.
• Effective leadership skills and ability to foster team productivity.
• Sound financial acumen.

Education / Certifications

• Essential: Minimum bachelor’s degree in a scientific discipline or general management.
• Preferred: Advanced degree (Masters, MBA, MD, PhD).

Languages

• English

EEO Statement

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. As part of the application process, please let the recruitment team know if you require any adjustments or support.