Head of Study, Site Management and Monitoring

The Head of Study, Site Management and Monitoring is a senior leadership role within Clinical Development Operations, accountable for the strategic oversight and operational excellence of Ipsen’s global Country Operations activities under a Functional Service Provider (FSP) delivery model. The role provides end‑to‑end leadership across the clinical trial lifecycle at country and site level, from feasibility and site selection through study start‑up, site management, monitoring (including risk‑based), study close‑out, and inspection readiness. This position is a critical enabler of Ipsen’s future operating model, driving the transition from traditional outsourcing approaches to a scalable, performance‑driven FSP framework.

The role ensures consistent, compliant, and high‑quality execution across countries and studies while maintaining clear process ownership, governance, and oversight of FSP partners delivering site‑level activities on Ipsen’s behalf. Acting as the single accountable owner for Study, Site Management and Monitoring strategy, the role ensures alignment with clinical development objectives, regulatory expectations, and quality standards. The role partners closely with CDO TA Clinical Operations, Quality, Data Management, Strategy and Operations, Biostatistics, Medical, Safety, Regulatory Affairs, and Country Medical Affairs to enable timely study delivery, robust oversight, and inspection‑ready execution at all times.

The Head of Study, Site Management and Monitoring will define and execute Ipsen’s global Site Engagement Strategy, ensuring a portfolio‑led, data‑driven approach to investigator relationships. Lead the identification and prioritization of strategic sites, fostering long‑term partnerships that enhance site experience, operational performance, and Ipsen’s reputation as a sponsor of choice. As a key member of the CDO leadership team, this role shapes Ipsen’s long‑term site engagement and monitoring strategy, focusing on operational efficiency, risk‑based approaches, data‑driven oversight, and continuous improvement—ultimately ensuring high‑performing sites, reliable data, and positive investigator relationships across Ipsen’s global portfolio.

Main Responsibilities & Technical Competencies

• Establish partnerships with FSP provider(s) to ensure delivery of the IPSEN portfolio of work.
• 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 project delivery to agreed timelines, including patient recruitment targets.
• Build, develop and motivate a high‑performing internal oversight 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, and regulatory compliance.
• Define, in collaboration with the CDO LT, Ipsen’s global Study, Site Management and Monitoring strategy aligned with the broader CDO FSP operating model and enterprise clinical development objectives.
• Lead the design, implementation, and ongoing optimization of Ipsen’s FSP‑based Country Operations and Monitoring model.
• Serve as the accountable business owner for all country/site‑level operational processes, ensuring clarity of roles between Ipsen and FSP partners.
• Translate clinical portfolio needs into scalable, sustainable Study, Site Management and Monitoring solutions across therapeutic areas and regions.
• Contribute to CDO and clinical development governance forums, representing site‑level execution, risks, and performance trends.
• Provide end‑to‑end oversight of FSP partners delivering country feasibility and site identification, site selection and initiation, study start‑up activities, recruitment to agreed targets, study close‑out and inspection readiness activities.
• Collaborate with CDO and global partners to define and maintain clear governance structures, including KPIs, SLAs, escalation pathways, and performance standards.
• Ensure consistent application of Ipsen standards, SOPs, and quality expectations across all FSP‑delivered activities.
• 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.
• In collaboration with appropriate global functions, establish standardized, 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, and site initiation readiness.
• Monitor start‑up performance metrics and proactively address delays or bottlenecks.
• Partner with Data Management & Central Monitoring on the implementation of 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.
• 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, site documentation and essential document quality, and inspection preparedness activities.
• Define and own Ipsen’s global Site Engagement Strategy, aligned to clinical development priorities, therapeutic focus, and portfolio growth.
• Establish a structured approach to understanding Ipsen’s site landscape using which to lead the identification of priority and strategic sites.
• Define, build, and grow the IPSEN internal Study, Study, Site Management and Monitoring organisation.
• Ensure all Study, Site Management and Monitoring activities comply with ICH‑GCP, applicable regional and local regulations, and Ipsen SOPs, policies, and quality standards.
• Embed proactive risk identification and mitigation at site and country level.
• Define and oversee a robust performance management framework for Study, Site Management and Monitoring activities.
• Identify trends and risks, drive evidence‑based decision‑making, and continuously improve efficiency and quality.
• Lead and develop high‑performing internal teams and matrixed functions supporting Study, Site Management and Monitoring.

Knowledge & Experience

• 15+ years’ experience within pharmaceutical/biotech or related industry with track record of transformational leadership across a global cross‑functional working environment.
• 15+ years of experience leading Country Operations teams of different sizes and operational models across all trial types.
• Extensive 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 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.
• Demonstrated ability to provide visionary and strategic leadership.
• Proven influencer and change agent with superior project management capabilities.
• Strong understanding of clinical systems and business process design.
• Effective leadership skills and proven ability to foster team productivity and cohesiveness in changing environments.

Education / Certifications (essential)

• A minimum of a bachelor’s degree in a scientific discipline or general management is required.

Education / Certifications (preferred)

• Advanced degree (e.g., Masters, MBA, MD, PhD) is highly preferred.

Language(s) (essential)

• English