Title: Head of Study, Site Management and Monitoring
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!

Job Description
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.

Main Responsibilities & Technical Competencies

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 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.
• Contribute as a member of the CDO leadership team, supporting strategic planning, budget management, external environment influencing etc.

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; Cross country and in country Study Management.
• Collaborate with CDO (e.g. Partnerships Team) and global partners (e.g. Procurement) to define and maintain clear governance structures, including KPIs, SLAs, escalation pathways, and performance standards.
• Define and create, in collaboration (e.g. with Business Enablement and Compliance), a clear Study/Study, Site Management and Monitoring Process Framework.
• 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.

Country Feasibility, Site Selection & Start‑Up Oversight

• 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 (in partnership with Regulatory/Start‑Up teams); Site initiation readiness.
• Monitor start‑up performance metrics and proactively address delays or bottlenecks.

Site Management & Monitoring Excellence
Partner (e.g. 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
• Investigational product compliance oversight
• Source data verification, source document review and data quality oversight.

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 regulatory inspections and audits, acting as a senior sponsor representative for Study, Site Management and Monitoring matters.

Site Engagement Strategy
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, differentiating:

• Key global and regional strategic partners
• High‑performing operational delivery sites.
• Emerging or development sites critical to pipeline growth

IPSEN Team Leadership
Define, build, and grow the IPSEN internal Study, Study, Site Management and Monitoring organisation. Overseeing the team of internal Clinical Trial Managers (CTMs) who will be responsible for Study Management within a cluster of countries and the Sr Clinical Research Associates. Partner with appropriate groups e.g. Training to ensure a highly skilled team focused on delivery.

Quality, Compliance & Risk Management
Ensure all Study, Site Management and Monitoring activities comply with:

• ICH‑GCP
• Applicable regional and local regulations
• Ipsen SOPs, policies, and quality standards

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 (including Early Development).
• 15+ years’ people/project management experience.
• 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. Track record of managing FDA/EMA inspections.
• A minimum of a bachelor’s degree in a scientific discipline or general management is required.

We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities.