Head of Business Enablement and Compliance

Job description

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. 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! For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram. Job Description: Job Title: Head of Business Enablement and Compliance Division / Function: Clinical Development Operations, Research and Development Manager’s Job Title: Head of Clinical Development Operations Location: US, UK or France WHAT - 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. This 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. WHAT - 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. 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. Clinical System’s 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 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. 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 that 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. Ensures effective onboarding and handover process for CDO