Head of Study, Site Management and Monitoring

Head Of Study, Site Management And Monitoring

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!

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 (inc 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 Head Of Study, Site Management And Monitoring 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.

Trial Delivery

• 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, quality and regulatory compliance.

Strategic Leadership & Operating Model Definition

• 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…