Head of Business Enablement and Compliance

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:

Head of Business Enablement and Compliance

Division / Function:

Clinical Development Operations Research and Development

Managers Job Title:

Head of Clinical Development Operations

Location:

US UK or France

WHAT - Summary & Purpose of the Position

The Head of Business Enablement and Compliance (BE&C) will be a critical leadership role whose responsibilities will include establishing and optimizing through continuous improvement key capabilities for IPSEN focusing on building a framework for internal business processes ownership business management of key Clinical systems (CTMS/TMF etc.) training and Compliance ensuring these capabilities effectively support the operational backbone of Clinical Development Operations and broader IPSEN.

This BE&C Head reports to the Global Head of Clinical Development Operations (CDO) and leads a team of 6 direct reports. This individual will be an active member of the CDO Leadership Team and will contribute their cross functional expertise to support in the shaping of CDO Strategy and this role the individual will partner closely with the different R&D Medical and enabling functions (e.g. IT Quality etc.) to shape and optimise these capabilities in support of clinical trial planning execution close out and site partnership/engagement.

This individual will bring extensive experience in ICH-GCP and Regulatory requirements to shape IPSENs strategies for business process training IPSEN staff and vendors whilst ensuring a culture and practice of inspection readiness. They will champion these new ways of working across R&D/Medical identifying opportunities and best practices to elevate Ipsen clinical development activities to best-in-class standard.

WHAT - Main Responsibilities & Technical Competencies

Leadership

• Provide strategic leadership to a multifunctional team setting vision priorities and expectations that enable highquality delivery across compliance training systems support and business process ownership.
• Coach mentor and develop team members to build deep functional expertise foster a culture of accountability and support longterm talent development within Clinical Development Operations.
• Create an inclusive collaborative and highperforming team environment aligned with the Ipsen Way of Being encouraging innovation continuous improvement and shared learning.
• Serve as an active and influential member of the CDO senior leadership team contributing to organizational strategy portfolio execution and crossfunctional decisionmaking.
• Build strong partnerships with senior leaders across Clinical Development Operations Quality Medical Regulatory and Digital/Data organizations to ensure alignment transparency and effective crossfunctional delivery.
• Lead/sponsor change initiatives that strengthen operational excellence and support the successful adoption of new processes systems and ways of working across the global organization.

Business Process Ownership

• Responsible for IPSENs Clinical Development SOP strategy in collaboration with the Global Quality team. Ensures consistency of approach and alignment on standard practices across functions and teams including GMA where applicable.
• Ensures a clear plan for process management in-line with IPSENs desire to move toward Functional Service Provision.
• Establishes a clear Business Process Ownership framework providing clarity and transparency on how SOPs are organized enabling their effective use.
• Ensure that the SOPs are fit for purpose and captures applicable corrective actions from the audits findings.
• Outlines process for review/approval of the SOPs.
• Outlines the process for implementation of these SOPs and partners.

Clinical Systems

• Provide strategic oversight and direction to the clinical system teams (CTMS/TMF etc.) ensuring clear vision roadmap and integrations align with enterprise clinical operations strategy and the broader digital ecosystem.
• Establish and lead governance frameworks that guide crosssystem integration data stewardship quality and compliance ensuring sustained alignment with GxP and internal standards.
• Oversee prioritization resource allocation and performance management for clinical platform evolution ensuring stability scalability and longterm digital enablement for clinical teams.
• Ensure effective partnership across Clinical Operations Digital/Data functions Quality and IT by empowering teams to translate business needs into system capabilities adoption strategies and user experience improvements.
• Drive continuous improvement and digital transformation by guiding the teams to identify AI/innovation opportunities enhance workflows and oversight and strengthen Ipsens clinical systems ecosystem.

Training

• Oversee the design governance and continuous improvement of global rolebased training curricula onboarding programs and competency frameworks across clinical and enabling functions.
• Ensure Learning Management Systems (LMS) and training processes meet compliance requirements including GxP inspection readiness and auditable documentation standards.
• Lead the development and execution of training strategies that support new systems processes and organizational changes driving high adoption and sustained performance improvements.
• Partner with functional leaders e.g. Quality and HR Learning teams to ensure training content is accurate standardized current and effectively delivered across global teams.
• Monitor training performance through metrics dashboards and compliance indicators using insights to guide prioritization resource allocation and continuous capability enhancements.
• Build and mentor a highperforming Training team fostering innovation collaboration and a culture of continuous learning aligned with the Ipsen Way of Being.

Compliance

• Directs and oversees the Compliance team ensuring robust monitoring of compliance risks and that mitigation and remediation plans are effectively prioritized resourced and delivered.
• Create and oversee a framework for QC checks compliance monitoring and TMF/training documentation reviews ensuring that risk signals are escalated appropriately and addressed with timely highquality corrective actions.
• Guide and support the team in preparation for audits inspections and Quality Reviews ensuring crossfunctional alignment with clinical operations quality and regulatory partners.
• Ensure strong CAPA governance by reviewing rootcause analyses validating CAPA effectiveness and fostering a consistent riskbased approach across countries and studies.
• Oversee and Partner (e.g. CROs) the teams assessment of local regulatory intelligence and procedural document updates ensuring that changes are translated into clear operational guidance and incorporated into quality systems.
• Ensures effective onboarding and handover process for CDO staff and Contractors.
• Enables a centralized system for storage and rapid retrieval of job descriptions training files and CVs as required under ICH-GCP standards. Includes the mechanism for periodic review of such documents for audit/inspection readiness.
• Ensures a process of monitoring across CDO of emerging compliance concerns and/or and reviews policy and procedural deviations (business and GCP) that impact CDO objectives.
• Enables a mechanism for trending across CDO audit/inspection root cause analyses for lessons learned and drives review meetings for consideration of adjustments to operational procedures/training etc. where necessary.

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.

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.

Ensures Accountability

Holding self and others accountable to meet commitments.

Ensures single accountable referents per task project outcome.
Builds environment where people ask for clarification when accountabilities are unclear.
Consults/seeks stakeholder views and ensures decisions are made by consent vs consensus.
Takes personal accountability for decisions actions successes and failures.
Follows through on commitment and makes sure others do the same.

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.
Communicates transparently tells it how it is while keeping communication respectful.
Builds clear and crisp messages with structure and focus.
Demonstrates gravitas.

Cultivate Innovation

Creating new and better ways for the organization to be successful.

Questions statusquo and adopt new approaches;
Has vision brings ideas and turns them into actions.
Thinks outside the box reframes problems;
Encourages and integrates different perspectives.

Instils Trust

Gaining the confidence and trust of others through honesty integrity and authenticity.

Displays approachability and humility rolemodels learning behaviours.
Gains confidence and trust of others through honesty integrity transparency and authenticity.

HOW - Knowledge & Experience

Knowledge & Experience (essential):

• 10 years experience within pharmaceutical/biotech or related industry with track record of transformational leadership across a global cross-functional working environment.
• 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.
• 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.
• 6 years people/project management experience (e.g. leading project teams operational teams cross functional teams through operational change and transformation).
• 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 preferred.

Language(s) (essential):

• English