Head of Study, Site Management and Monitoring

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 companys success. Join us on our journey towards sustainable growth creating real impact on patients and society!

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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 Ipsens global Country Operations activities under a Functional Service Provider (FSP) delivery model. The role provides endtoend leadership across the clinical trial lifecycle at country and site level from feasibility and site selection through study startup site management monitoring (inc Risk Based) study closeout and inspection readiness.

This position is a critical enabler of Ipsens future operating model driving the transition from traditional outsourcing approaches to a scalable performancedriven FSP framework. The role ensures consistent compliant and highquality execution across countries and studies while maintaining clear process ownership governance and oversight of FSP partners delivering sitelevel activities on Ipsens 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 inspectionready execution at all times.

The Head of Study Site Management and Monitoring will define and execute Ipsens global Site Engagement Strategy ensuring a portfolioled datadriven approach to investigator relationships. Lead the identification and prioritization of strategic sites fostering longterm partnerships that enhance site experience operational performance and Ipsens reputation as a sponsor of choice.

As a key member of the CDO leadership team this role shapes Ipsens longterm site engagement and monitoring strategy focusing on operational efficiency riskbased approaches datadriven oversight and continuous improvementultimately ensuring highperforming sites reliable data and positive investigator relationships across Ipsens 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 highperforming 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 Ipsens 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 Ipsens FSPbased Country Operations and Monitoring model.
• Serve as the accountable business owner for all country/sitelevel 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 sitelevel 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 endtoend oversight of FSP partners delivering:
  • Country feasibility and site identification
  • Site selection and initiation
  • Study startup activities (including regulatory and contractual interfaces)
  • Recruitment to agreed targets.
  • Study Site Management and Monitoring.
  • Study closeout 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 FSPdelivered 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 sitelevel execution.

Country Feasibility Site Selection & StartUp Oversight

• In collaboration with appropriate global functions establish standardized datadriven 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 startup execution including:
  • Site contracting and budget negotiations.
  • Regulatory and ethics submissions (in partnership with Regulatory/StartUp teams).
  • Site initiation readiness.
• Monitor startup performance metrics and proactively address delays or bottlenecks.

Site Management & Monitoring Excellence

Partner (e.g. with Data Management & Central Monitoring) on the implementation of riskbased monitoring (RBQM) strategies in line with regulatory expectations and Ipsen standards. Ensure effective monitoring delivery across studies including:

• Onsite remote and centralized monitoring activities
• Investigational product compliance oversight
• Source data verification source document review and data quality oversight.

Partner with Data Management Biostatistics and Central Monitoring functions to ensure integrated oversight and risk mitigation. Drive consistency in site execution issue management and protocol adherence across all regions and studies.

Study CloseOut & Inspection Readiness

Ensure timely and compliant study and site closeout activities across Ipsens 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 Ipsens global Site Engagement Strategy aligned to clinical development priorities therapeutic focus and portfolio growth. Establish a structured approach to understanding Ipsens site landscape using which to lead the identification of priority and strategic sites differentiating:

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

Partner with key stakeholders (e.g. Medical) to ensure that a robust differentiated site engagement strategy is put into place.

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:

• ICHGCP
• Applicable regional and local regulations
• 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. Promote a culture of quality accountability and patient safety across internal teams and FSP partners.

Performance Management Metrics & Continuous Improvement

Define and oversee a robust performance management framework for Study Site Management and Monitoring activities.

Leverage operational quality and performance data to:

• Identify trends and risks.
• Drive evidencebased decisionmaking.
• Continuously improve efficiency and quality.

Partner with Strategy and Operations and Business Enablement teams to enhance reporting and oversight capabilities (e.g. dashboards KPIs). Champion innovation digital enablement and simplification across sitelevel processes where appropriate.

Leadership Stakeholder Management & Culture

Lead and develop highperforming internal teams and matrixed functions supporting Study Site Management and Monitoring.

Act as a key interface with senior stakeholders across Clinical Development Quality Regulatory Medical and Global Operations. Represent Ipsen externally with investigators partners and vendors as required. Foster a culture of collaboration accountability and continuous learning across Ipsen and its partner ecosystem.

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 (e.g. leading project teams operational teams cross functional teams through operational change and transformation).
• 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. Track record of managing FDA/EMA inspections.
• Demonstrated ability to provide visionary and strategic leadership is required.
• 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.
• Extensive knowledge of Good Clinical Practice and related global regulatory and compliance requirements for clinical studies.
• 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
• Sound financial acumen is required

Education / Certifications (essential):

• A minimum of a bachelors 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

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