Head of Business Enablement and Compliance

Cookie Notice WHAT - Summary & Purpose of the Position WHAT - Main Responsibilities & Technical Competencies 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. 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. Outlines the process for implementation of these SOPs and partners. 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. Oversee the design, governance, and continuous improvement of global role based training curricula, onboarding programs, and competency frameworks across clinical and enabling functions. Ensure Learning Management Systems (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. 10+ years' experience within pharmaceutical/biotech or related industry with track record of transformational leadership across a global cross-functional working environment. Experience in clinical development, clinical operations, quality, compliance, or related areas in the pharmaceutical or biotech industry. Deep understanding of the clinical trial landscape and commitment to innovation, creativity, and operational excellence. Extensive, demonstrated, 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. Ability to provide visionary and strategic leadership is required Experience in large-scale organisational change management/implementation programs. Proven influencer and change agent with superior project management capabilities. Project management excellence in planning, prioritisation, problem solving and organisational skills. Used to managing multiple priorities in a dynamic environment. Agile mind-set. Experience in managing internal stakeholders and used to communicating across all levels of the organization including 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, etc.) and business process design. Effective leadership skills and proven ability to foster team productivity and cohesiveness in changing environment is required Sound financial acumen is required Get In TouchIntroduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match.