Head eTMF Systems

About Ipsen

Ipsen is a mid‑sized global biopharmaceutical company focused on transformative medicines in oncology, rare disease, and neuroscience. With nearly 100 years of development experience and global hubs in the U.S., France, and the U.K., Ipsen tackles areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are dedicated to bringing medicines to patients in 88 countries, championing human‑centric leadership and fostering a culture of collaboration, excellence, and impact.

Job Description

The Head eTMF is a strategic and operational leader responsible for oversight, management, and continuous improvement of Ipsen’s eTMF ecosystem, ensuring that Trial Master Files are always inspection‑ready and fully compliant with regulatory standards (e.g., ICH‑GCP, data protection regulations). The role owns Ipsen’s Veeva Vault eTMF system from a business perspective, driving strategy, governance, processes, training, and user adoption across functions and geographies in close partnership with Clinical Operations, R&D IT, Quality, Digital, and external vendors/CROs.

Main Responsibilities & Technical Competencies

• Strategic Leadership & Governance: Lead the global eTMF strategy and roadmap, ensuring alignment with Ipsen’s R&D and CDO transformation initiatives. Act as the eTMF business process owner, accountable for the quality, compliance, and fitness‑for‑purpose of TMF content, processes, and systems. Ensure TMF operating standards, electronic clinical systems, data standards, and related processes support compliant, efficient end‑to‑end study management. Serve as subject‑matter expert for eTMF management and inspection readiness, representing the function in audits, inspections, and governance forums. Provide strategic oversight and governance of all eTMF‑related activities and vendors, ensuring decisions are data‑driven and risk‑based.
• System Implementation & Oversight: Lead governance for updates, validation, and implementation of eTMF system releases (e.g., Veeva Vault upgrades, integrations). Define and maintain eTMF standards (SOPs, business rules, templates, taxonomies, performance metrics) and ensure all end‑users are trained and qualified. Own and monitor TMF performance objectives and metrics (completeness, timeliness, quality) and drive corrective and preventive actions. Monitor TMF health status, including system usage and quality checks, to ensure consistent compliance with SOPs and regulatory standards. Drive development of innovative, risk‑based eTMF operational processes that inform business decisions, mitigate compliance risk, and embed leading practices.
• Vendor & Stakeholder Management: Establish and lead eTMF functional governance with CROs and external partners to ensure alignment on processes, timelines, and quality standards. Drive standardization of eTMF practices across Ipsen’s internal teams, eTMF vendor, and CROs/third‑party providers. Partner with R&D IT, Digital, and other vendors on eTMF services, integrations, and contractor management, ensuring appropriate governance forums. Ensure vendor performance meets contractual obligations and Ipsen standards, using KPIs and dashboards to provide visibility and enable proactive issue management.
• Process Improvement & Compliance: Promote a risk‑based approach to maintaining a continuous state of audit and inspection readiness across all TMFs. Ensure eTMF processes and system usage comply with applicable regulations and guidelines (ICH‑GCP, data protection, local regulatory expectations) and Ipsen SOPs. Identify, assess, and escape significant quality and compliance risks, leading or supporting investigations, root‑cause analysis, and remediation initiatives. Identify and lead eTMF system and process improvement initiatives, using data insights, user feedback, and industry benchmarks. Collaborate with CDO leadership, Quality, and other internal stakeholders on SOP development, controlled document updates, and cross‑functional process harmonization.
• Integration & Acquisition Support: Provide eTMF leadership and expertise for integration of acquired companies, licensed assets, or strategic partnerships. Collaborate with the CDO Integration Lead and other workstreams to plan and deliver eTMF migration activities, ensuring robust governance, data integrity, and timely adoption of Ipsen standards.
• User Support, Change Management & Training: Ensure fit‑for‑purpose training programmes, user guides, SOPs, and e‑learning materials are in place, regularly reviewed, and updated. Drive effective change management and user adoption for new releases, process changes, and integrations, in partnership with CDO, R&D IT, and local teams. Collect, monitor, and act on user feedback to improve system usability, training effectiveness, and ways of working. Act as escalation point for complex user issues and recurring system challenges and ensure sustainable solutions are implemented.
• Team Leadership & People Management: Lead, coach, and develop the eTMF team to deliver high performance, strong collaboration, and a culture of continuous improvement. Set clear objectives, priorities, and development plans for team members, aligned to Ipsen’s leadership competencies and ways of being. Foster a collaborative, inclusive, and globally minded team culture, working across functions, geography, and time zones. Demonstrate strong leadership in driving eTMF user acceptance and inspection‑readiness as a core enabler of clinical excellence.

Key Technical Competencies

• Expert knowledge of TMF/eTMF processes, regulatory requirements, and inspection‑readiness standards.
• In‑depth experience with Veeva Vault eTMF (or similar), including configuration, validation, release management, and integrations.
• Strong understanding of GxP system validation, data integrity principles, and the clinical trial lifecycle.
• Ability to design and implement TMF metrics, dashboards, and data‑driven improvement initiatives.
• Strong vendor and CRO governance skills, including contract oversight and performance management.

Behavioural Competencies Required

• Excellence in Execution – Plans and prioritises work to ensure TMFs are always inspection‑ready, even under pressure or tight timelines; translates strategy into clear goals, timelines, and KPIs; drives a culture of operational discipline and continuous improvement.
• Manages Complexity – Makes sense of complex and sometimes contradictory information across systems, vendors, and studies; simplifies complexity for others; anticipates issues and prepares robust pragmatic solutions.
• Collaborates & Builds Effective Teams – Builds strong partnerships with Clinical Operations, R&D IT, Quality, Digital, CROs, and other stakeholders; creates a high‑trust, inclusive environment where diverse perspectives are valued; leverages strengths across the network to solve problems and accelerate outcomes.
• Communicates Effectively & Influences – Communicates complex system, process, and regulatory topics in a clear, accessible way for various audiences; uses data, stories, and patient‑centred arguments to influence decisions and secure alignment; listens actively, seeks feedback, and adapts style to build trust.
• Ensures Accountability – Sets and reinforces clear accountabilities for eTMF quality, completeness, and timeliness; holds self and others to commitments; role‑models Ipsen’s values and takes ownership for successes, failures, and learning.

Knowledge & Experience (Essential)

• Demonstrated expertise in TMF/eTMF management within the pharmaceutical or biotech industry, including deep understanding of TMF Reference Model, ICH‑GCP, and inspection expectations.
• Proven track record in owning and optimizing an enterprise eTMF platform, preferably Veeva Vault, including configuration changes, release management, validation, and integrations.
• Experience designing and implementing TMF standards, governance frameworks, SOPs, business rules, and training for global user communities.
• Strong experience managing relationships and performance with CROs and other external vendors for TMF/eTMF services.
• Evidence of leading cross‑functional, global initiatives and successfully implementing change in a regulated environment.
• Demonstrated ability to interpret data/metrics to drive continuous improvement and informed decision‑making.

Knowledge & Experience (Preferred)

• Experience in mid‑sized global biopharma/biotech organisations with evolving R&D operating models.
• Experience with system migrations and eTMF integration in the context of acquisitions, divestments, or partnerships.
• Previous leadership of distributed/global teams and virtual collaboration environments.
• Familiarity with the broader clinical systems landscape (e.g., CTMS, RTSM, EDC) and data flows into TMF.

Education / Certifications (Essential)

• Bachelor’s degree (or equivalent) in Life Sciences, Pharmacy, Information Technology or a related discipline.

Education / Certifications (Preferred)

• Advanced degree (e.g., MSc, PharmD, PhD, MBA) in a relevant discipline.
• Relevant professional certifications (e.g., GCP, clinical research, project management) are an advantage.

Language(s) (Essential)

• English – fluent (written and spoken).

Language(s) (Preferred)

• Additional languages relevant to Ipsen’s key geographies are an asset.

We are committed to creating a workplace where everyone feels heard, valued, and supported, embracing “The Real Us”. We value diverse perspectives and experiences, fostering inclusion and equal opportunity. If you require adjustments or support during the application process, please let the recruitment team know; your application will be handled with care and will not affect the outcome.