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About the Role

This leadership role, reporting to the Head of Study, Site Management and Monitoring (SSMM), is 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, ensuring consistent, compliant, and high-quality execution of Ipsen studies.

Responsibilities

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.
Provide end-to-end oversight of FSP partners delivering country feasibility and site identification, site selection and initiation, study start-up activities, recruitment, study, site management and monitoring, study close-out and inspection readiness activities.
Ensure consistent application of Ipsen standards, SOPs, and quality expectations across all FSP-delivered activities.
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.
Establish strategic, data-driven approaches to country feasibility and site selection.
Oversee site feasibility execution and validation to support realistic enrolment projections and operational planning.
Ensure efficient, compliant study start-up execution, including site contracting, budget negotiations, regulatory and ethics submissions, and site initiation readiness.
Monitor start-up performance metrics and proactively address delays or bottlenecks.
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, and source data verification.
Partner with Data Management, Biostatistics, and Central Monitoring functions to ensure integrated oversight and risk mitigation.
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 inspection preparedness activities.
Support country focused regulatory inspections and audits, acting as a senior sponsor representative for Study, Site Management and Monitoring matters.
Own and implement Ipsen’s Site Engagement Strategy at country/cluster level.
Be accountable for the health of investigator sites, including performance, recruitment/retention and quality.
Partner with key stakeholders to ensure a robust, differentiated site engagement strategy is put into place.
Own study level site segmentation strategy at country/cluster and, where necessary, will co-ordinate site segmentation plan for an asset globally.
Define, build, and grow the IPSEN internal Study, Site Management and Monitoring organisation.
Ensure all country level 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.
Collaborate closely with Quality Assurance to address audit findings, CAPAs, and continuous improvement initiatives.
Oversee a robust performance management framework for country level Study, Site Management and Monitoring activities.
Leverage operational, quality, and performance data to identify trends and risks, drive evidence-based decision-making, and continuously improve efficiency and quality.
Deliver and continuously improve key country-level performance metrics.
Partner with Strategy and Operations and Business Enablement teams to enhance reporting and oversight capabilities.
Lead and develop high-performing internal, country/cluster teams and matrixed functions supporting Study, Site Management and Monitoring.
Support resource forecasting and management.
Act as a key interface with stakeholders across Clinical Development, Quality, Regulatory, Medical, and Global Operations.
Embody a culture of continuous improvement across the Site Management and Monitoring team.
Demonstrate leadership of change and be active in assuring change management practices are applied across the team.
Acts as a senior external ambassador for Ipsen, engaging with key health authorities, investigators, site networks, pharmaceutical associations, and institutional leadership.

Requirements

A minimum 10 years experience in Clinical Trials.
Demonstrated experience leading Country Operations teams of different sizes and operational models across all trial types.
Experience in Site Management and Monitoring required.
Demonstrated experience of people/project management experience.
Extensive experience in clinical development, clinical operations, quality, compliance, or related areas in the pharmaceutical or biotech industry.
Demonstrated 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.
Track record of managing FDA/EMA inspections.
Experience in large-scale organisational change management/implementation programs.
Proven influencer and change agent with superior project management capabilities.
Project management excellence in planning, prioritisation, problem solving and organisational skills.
Used to managing multiple priorities in a dynamic environment.
Agile mind-set.
Experience in managing internal stakeholders and used to communicating across all levels of the organization including up to ELT level.
Strong understanding of clinical systems (eTMF, CTMS, QMS, etc.) and business process design.
Effective leadership skills and proven ability to foster team productivity and cohesiveness in changing environment is required.
Financial acumen is required.
Experience including Early Development in Oncology (or in patients) preferred.

Skills

Clinical Trials
Country Operations
Site Management
Monitoring
People Management
Project Management
Clinical Development
Clinical Operations
Quality Assurance
Compliance
Drug Development Processes
ICH-GCP
21 CFR Part 11
Health Authority Regulations
Audit/Inspection Readiness
Organizational Change Management
Project Management Excellence
Agile Mindset
Stakeholder Management
Clinical Systems (eTMF, CTMS, QMS)
Business Process Design
Leadership
Financial Acumen
Early Development in Oncology

Location

London

Work Type

Full-time

Experience Level

Minimum 10 years experience in Clinical Trials
Extensive experience in clinical development, clinical operations, quality, compliance, or related areas

Education Level

Minimum of a Bachelor’s degree (University/college degree) in a scientific discipline or general management is required.
Advanced degree (e.g., Masters, MBA, MD, PhD , Pharm D) is preferred.

About the Company

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.

Equal Opportunity

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.
When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions.
Together we strive to better understand the communities we serve.
This means we also want to help you perform at your best when applying for a role with us.
If you require any adjustments or support during the application process, please let the recruitment team know.
This information will be handled with care and will not affect the outcome of your application.