CDO Country Cluster Head - US based/remote

Title: CDO Country Cluster Head - US based/remote Company: Ipsen Biopharmaceuticals Inc. 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: The Country-Cluster Lead is a leadership role, reporting to the Head of Study, Site Management and Monitoring (SSMM) within Clinical Development Operations, accountable for the oversight and operational excellence of Ipsen’s Country Operations activities under a Functional Service Provider (FSP) delivery model. The role provides leadership across the clinical trial lifecycle at country and site level, from feasibility and site selection through study start‑up, site management, monitoring (inc Risk Based), study close‑out, and inspection readiness. The role ensures consistent, compliant, and high‑quality execution at country level IPSEN studies in the CDO portfolio and will be accountable for governance, and oversight of FSP partners delivering country and site‑level activities on Ipsen’s behalf. The individual will require a ‘Think Local, Act Global’ mindset understanding local needs, within their Country/Cluster, but an ability to think strategically and to align globally. The role is accountable for ensuring high‑performing sites, reliable data, and effective, best in class investigator relationships across Ipsen’s global portfolio. Acts as single point of accountability for country/cluster level performance. The Country-Cluster Lead manages IPSEN staff, operating within that Cluster including Functional Managers, Cluster Trial Managers and Principal Clinical Research Associates. They also collaborate closely with FSP Leadership and Staff in their Cluster/Country. Trial Delivery Partner with functional leaders and FSP partners to ensure clinical trials are delivered on time, within budget, and in-line with Quality standards. Overall accountability for country(s) project delivery to agreed timelines, including patient recruitment targets. Build, develop and motivate a high‑performing internal team and ensure FSP providers are bringing the right resource on board to ensure overall delivery. Drive continuous improvement of Clinical Operations processes and procedures to optimise development speed, quality, quality and regulatory compliance Functional Service Provider (FSP) Oversight & Governance Provide end‑to‑end oversight of FSP partners delivering: Country feasibility and site identification Site selection and initiation Study start‑up activities (including regulatory and contractual interfaces) Recruitment to agreed targets. Study, Site Management and Monitoring. Study close‑out and inspection readiness activities. In country Study Management (CTM role) With Business Enablement and Compliance, contribute to creation of a clear Study + Site Management and Monitoring Process Framework Ensure consistent application of Ipsen standards, SOPs, and quality expectations across all FSP‑delivered activities. At cluster/country level, drive a strong partnership culture with FSP providers while maintaining appropriate independence and sponsor oversight Lead escalation and remediation of performance, quality, or compliance issues related to country or site‑level execution Act as senior IPSEN counterpart to FSP leadership within the cluster Influence and direct resourcing decisions and staff capability decisions at country/cluster level Country Feasibility, Site Selection & Start ‑ Up Oversight In collaboration with appropriate global functions, establish strategic, data‑driven approaches to country feasibility and site selection, ensuring optimal country and site choices. Oversee site feasibility execution and validation to support realistic enrolment projections and operational planning. Ensure efficient, compliant study start‑up execution, including: Site contracting and budget negotiations. Regulatory and ethics submissions (in partnership with applicable stakeholders e.g. Regulatory). Site initiation readiness Monitor start‑up performance metrics and proactively address delays or bottlenecks Site Management & Monitoring Excellence Implement risk‑based monitoring (RBQM) strategies in line with regulatory expectations and Ipsen standards. Ensure effective monitoring delivery across studies, including: On‑site, remote, and centralized monitoring activities Investigational product compliance oversight Source data verification, source document review and data quality oversight. Partner with Data Management, Biostatistics, and Central Monitoring functions to ensure integrated oversight and risk mitigation. Drive consistency in site execution, issue management, and protocol adherence across all regions and studies Study Close ‑ Out & Inspection Readiness Ensure timely and compliant study and site close‑out activities across Ipsen’s portfolio. Maintain continuous inspection readiness at site and country level, including oversight of: TMF completeness and quality (in collaboration with TMF leadership) Site documentation and essential document quality Inspection preparedness activities with FSP partners and internal stakeholders Support country focused regulatory inspections and audits, acting as a senior sponsor representative for Study, Site Management and Monitoring matters. Site Engagement Strategy At country/cluster level, own and implement Ipsen’s Site Engagement Strategy, aligned to clinical development priorities, therapeutic focus, and portfolio growth. Establish a structured approach to understanding Ipsen’s site landscape using it to lead the identification of priority and strategic sites, differentiating: High‑performing operational delivery sites. Emerging or development sites critical to pipeline growth Sites in new/emerging