Head of Study, Site Management and Monitoring in London

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 endeavour 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 (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 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.

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, 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.
• 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.
• 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.
• Site Management & Monitoring Excellence: 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.
• 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.
• Site Engagement Strategy: Define and own Ipsen’s global Site Engagement Strategy, aligned to clinical development priorities, therapeutic focus, and portfolio 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.
• Quality, Compliance & Risk Management: Ensure all Study, Site Management and Monitoring activities comply with ICH‑GCP, applicable regional and local regulations, and Ipsen SOPs, policies, and quality standards.
• Performance Management, Metrics & Continuous Improvement: Define and oversee a robust performance management framework for Study, Site Management and Monitoring activities.
• Leadership, Stakeholder Management & Culture: 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 (including Early Development).
• 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, 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.
• Demonstrated ability to provide visionary and strategic leadership is required.
• Proven influencer and change agent with superior project management capabilities.

Education / Certifications (essential): A minimum of a bachelor’s degree (University/college 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

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.