Director, Centralized Monitoring

Ipsen Biopharmaceuticals Inc.; Greater London; On-site; GBP 120,000 - 180,000; Full time

Job summary

Ipsen Biopharm Ltd in the United Kingdom seeks a Director, Centralized Monitoring to lead risk-based monitoring (RBM) strategies and governance across the clinical development portfolio. The role emphasizes advanced analytics, centralized data review, and innovative technologies to safeguard patient safety and data integrity while ensuring regulatory compliance.

The position requires strategic leadership of internal teams and external partners, alignment with global standards, and a drive to

Responsibilities

• Define and implement the Centralized monitoring and RBM strategy across the assigned region, ensuring alignment with the global CDO strategy.
• Establish policies, SOPs, and governance frameworks aligned with global regulations.
• Ensure consistent implementation across clinical programs within the assigned region and alignment with global standards.
• Provide input into protocol and study design.
• Interacts with and influences all levels of management and cross-functional team members in Clinical Development Operations to achieve high standards in Centralized Monitoring.
• Partner with Clinical Operations, Data Management, Biostatistics, Quality, and Technology teams to drive integrated data surveillance.
• Leads analytics and dashboard development to enable real-time data-driven decisions.
• Act as accountable leader during audits and inspections.
• Define roadmap for future Centralized monitoring capabilities, including AI, automation and advanced analytics.

Job description

Title:

Director, Centralized 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!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram .

Job Description:

WHAT - Summary & Purpose of the Position

The Centralized Monitoring Director is a leadership role responsible for defining, implementing, and governing Centralized and risk-based monitoring (RBM) strategies across the company's clinical development portfolio. This role ensures high-quality oversight of clinical trials by leveraging advanced analytics, Centralized data review, and innovative technologies to proactively identify and mitigate risks, safeguard patient safety, and ensure data integrity and regulatory compliance. As a sponsor-side leader, this role provides strategic direction and oversight of internal teams and external partners, ensuring alignment with global regulatory expectations and corporate quality standards.

WHAT - Main Responsibilities & Technical Competencies

Enterprise Strategy & Governance

• Define and implement the Centralized monitoring and RBM strategy across the assigned region, ensuring alignment with the global CDO strategy.
• Establish policies, SOPs, and governance frameworks aligned with global regulations.
• Ensure consistent implementation across clinical programs within the assigned region and alignment with global standards.
• Provide input into protocol and study design.
• Interacts with and influences all levels of management and cross-functional team members in Clinical Development Operations to achieve high standards in Centralized Monitoring.
• Partner with Clinical Operations, Data Management, Biostatistics, Quality, and Technology teams to drive integrated data surveillance.

Risk-Based Monitoring Leadership

• Provides strategic direction, leadership, and oversight to the assigned CM team, ensuring the successful delivery of CM activities and study deliverables across assigned projects.
• Leads the development, training, mentoring, and performance of departmental staff while fostering effective collaboration with cross-functional partners.
• Provides strategic oversight of Centralized monitoring activities to ensure quality, timely risk identification and data-driven decision making throughout study execution. Drive RBM adoption at study design stage.
• Determine and oversee Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) to enhance study success.
• Identify cross-study and portfolio-level risks.
• Monitor portfolio-level trends and recommend proactive mitigation strategies to senior leadership.

Oversight of Clinical Programs & Service Providers

• Oversee Centralized monitoring activities performed internally and by Service Providers.
• Ensure adherence to RBM standards and KPIs.
• Review monitoring outputs and risk signals.
• Serve as escalation point for critical risks.

Advanced Analytics & Data Insights

• Lead analytics and dashboard development.
• Enable real-time data-driven decision making.
• Collaborate with data management, clinical operations and biostatistics teams.

Inspection Readiness & Compliance

• Act as accountable leader during audits and inspections.
• Ensure regulatory compliance and inspection readiness.
• Support audits and regulatory inspections.

Innovation & Digital Transformation

• Define the roadmap for future Centralized monitoring capabilities, including AI, automation and advanced analytics.
• Implement advanced technologies including AI/ML.

Team Leadership & Development

• Build, lead and develop a high-performing Centralized Monitoring team, fostering technical excellence, accountability, collaboration and continuous improvement. Recruits, hires, and trains the front-line Centralized Monitoring team, including therapeutic area training, compliance training and study management-specific knowledge as required to perform assigned tasks.
• Foster a culture of quality and innovation.

HOW - Behavioural Competencies Required

Social Agility

Builds trusted relationships across Clinical Operations, Data Management, Biostatistics, Quality, Technology and external partners to achieve shared goals. Collaborates effectively across functions and geographies, influenc