Director, Clinical Trial Management Systems

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 Title:

Director Clinical Trial Management Systems

Division / Function:

Clinical Trial Excellence Clinical Development Operations

Managers Job Title:

Head of Clinical Trial Excellence

Location:

London UK - Paris France - Cambridge US

WHAT - Summary & Purpose of the Position

• Lead the vision and strategic evolution of the Clinical Trial Management System (CTMS) ensuring it effectively supports the operational backbone of Clinical Development Operations.
• Work in close partnership with clinical operations leaders technology leadership and cross-functional stakeholders to shape how CTMS capabilities support trial planning execution and site engagement.
• Serve as a strategic bridge between business needs and technology implementation helping ensure solutions are scalable sustainable and aligned with the broader clinical systems ecosystem.

WHAT - Main Responsibilities & Technical Competencies

Strategic System Ownership & Digital Leadership

• Serve as Ipsens enterprise system owner for CTMS defining the overall CTMS strategy that aligns with the organizations clinical operations goals and the long-term digital roadmap.
• Drive platform enhancements ensuring stability scalability and sustained alignment with Ipsens mission to create meaningful impact for patients and society.
• Champion the Ipsen Way of Being through purpose-driven leadership transparent decision-making and fostering an environment of global collaboration.

Cross-System Governance & Integration Excellence

• Lead cross-functional governance ensuring seamless integration and reliable data flow.
• Establish clear ownership and accountability for all CTMS-related integrations and data pipelines promoting simplicity efficiency and continuous improvement.
• Collaborate with Ipsen stakeholders in Clinical Operations Digital and Data Analytics Quality and IT to align digital capabilities with operational and scientific needs.

Quality Compliance & Systems Stewardship

• Oversee all CTMS validation testing documentation and change control activities ensuring compliance with GxP and Ipsens internal standards.
• Act as the senior escalation point for system performance cross-system workflow challenges and recurring data quality issues
• Ensure CTMS and connected platforms remain audit-ready and reflect Ipsens commitment to excellence and quality.

Partnership Enablement & User Experience

• Partner with study team operational leaders global and local affiliates to ensure CTMS features workflows and data structures directly support high-quality execution.
• Translate business needs into actionable system requirements and oversee training communications and user adoption strategies.
• Foster a culture of Learning & Sharing by promoting user community development system best practice dissemination and collaborative problem-solving.

Continuous Improvement & Digital Evolution

• Identify and drive digital transformation opportunities across clinical operations to enhance workflow efficiencies reporting oversight and cross-trial visibility.
• Collaborate with Ipsens digital and data organizations to explore new innovative capabilities that support study teams simplify processes and elevate trial delivery.
• Demonstrate leadership by delivering measurable impact through continuous system evolution and effective stewardship of Ipsens clinical ecosystem.

HOW - Behavioural Competencies Required

Competency Description

Competency Behavioural Markers

Drive Vision and Strategy

Seeing ahead to future possibilities and translating them into breakthrough strategies.

Painting a compelling picture of the vision and strategy that motivates others to action.

Paints a compelling picture of the vision (future status quo) and strategy that motivates others to action.

Manage Complexity

Making sense of complex high quantity and sometimes contradictory information to effectively solve problems.

Identifies contradictory information/demands/inputs to effectively solve problems.

Develops and evaluates alternative scenario and solutions.

Able to identify what truly matters and ruthlessly focus/prioritize on making decisions with real impact.

Influences

Using compelling arguments to gain support and commitment of others. Anticipating and balancing the needs of multiple stakeholders

Listens and observes actively (paraphrases summarizes uses body language) and reflects on what was said builds on what others are saying

Gets insights on objectives of other stakeholders and is able to identify common interests

Actively seeks win-win partnerships/solutions

Able to embark internal and/or external stakeholders without hierarchical relationships

Communicates Effectively

Developing and delivering multi-mode communications that convey a clear understanding of the unique needs of different audiences.

Asks open questions and digs deeper; shows care and respect for different perspectives (both verbally and non verbally) and able to relate to other points of view.

Communicates transparently tells it how it is while keeping the communication respectful.

Builds clear and crisp messages with structure and focus uses visual communication and storytelling to make the message easy to digest and connect with the outcomes.

Demonstrates gravitas.

Excellence in Execution

Planning and prioritizing work to meet commitments aligned with organizational goals.

Consistently achieving results even under tough circumstances.

Approaches priority setting and setting the stage through the lens of execution.

Establishes clarity about the goals accountabilities timelines and next steps; can identify/spot opportunities for real impact on patient and society.

Able to be focused and performance driven with clear KPIs.

Plans and aligns effectively (steps resources timelines etc.).

Displays a commitment to best practice sharing and setting.

Promotes single point of accountabilities.

HOW - Knowledge & Experience

Knowledge & Experience (essential):

• 58 years of experience with CTMS or similar clinical systems in roles such as system owner administrator or subject matter expert.
• Strong understanding of clinical study operations global trial execution workflows and regulated system environments.
• Proven ability to lead digital governance across multiple systems integrations and global stakeholder groups.
• Demonstrated capability to influence crossfunctional teams in a collaborative trustbased environment aligned with Ipsens values.
• Experience must include line management of global teams
• Strong analytical/critical thinking and decision-making abilities
• In-depth knowledge of ICH-GCP and other applicable worldwide regulations that govern clinical research.
• Audit/Inspection readiness exposure and CAPA governance.
• Excellent written and verbal communication skills

Knowledge & Experience (preferred):

• Experience in pharmaceutical or biotech clinical operations particularly within organizations emphasizing collaboration and patientcentered innovation.
• String knowledge of with adjacent systems (eTMF QMS EDC IRT) and enterprise digital transformation initiatives.

Education / Certifications (essential):

• Graduate degree (science preferred)

Language(s) (essential):

• Proficient in English

Language(s) (preferred):

• Proficient in French