Head of Business Enablement and Compliance

Job Title:

Head of Business Enablement and Compliance

Division / Function:

Clinical Development Operations, Research and Development

Manager’s 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 priorities. In 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 IPSEN’s 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 multi‑functional team, setting vision, priorities, and expectations that enable high‑quality 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 long‑term talent development within Clinical Development Operations.
• Create an inclusive, collaborative, and high‑performing 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 cross‑functional decision‑making.
• Build strong partnerships with senior leaders across Clinical Development Operations, Quality, Medical, Regulatory, and Digital/Data organizations to ensure alignment, transparency, and effective cross‑functional 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 IPSEN’s 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 System’s

• Provide strategic oversight and direction to the clinical system team’s (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 cross‑system 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 long‑term 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 Ipsen’s clinical systems ecosystem.

Training

• Oversee the design, governance, and continuous improvement of global role‑based 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 high‑performing 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, high‑quality corrective actions.
• Guide and support the team in preparation for audits, inspections, and Quality Reviews, ensuring cross‑functional alignment with clinical operations, quality, and regulatory partners.
• Ensure strong CAPA governance by reviewing root‑cause analyses, validating CAPA effectiveness, and fostering a consistent, risk‑based approach across countries and studies.
• Oversee and Partner (e.g. CROs) the team’s 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 status‑quo 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, role‑models 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 bachelor’s 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