Director Operations - Clinical Data Management

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!

The Director Operations - Clinical Data-Management is responsible for the management of critical, trial and non-trial specific activities and functions that support the Clinical Data Management organization.

He/She is responsible for leading the development of and oversight of administrative and trial and non-trial operations to help ensure Ipsen and Ipsen CDM meet or exceed Ipsen goals and objectives, maintain regulatory compliance, and effectively work with strategic partners.

He/She is an integral part of the CDM leadership team helping define and execute near and longer term strategies in collaboration with CDM and Ipsen leadership.

Non-trial, administrative operations responsibilities

• Define, implement, and oversee Quality Management (QM) within CDM.
• Works collaboratively with Asset Data Management leaders, Talent Acquisition (TA), and external vendors and partners to identify and secure personnel resources.
• Manages the CDM documentation environment such as Standard Operating Procedures (SOPs) and other working guidelines, procedures and processes.

Direct change management activities within CDM.

• Participate in operational governance with external partners.
• Track, manage, and report on CDM KPIs, KQIs, and other metrics.
• Contribute to innovation initiatives as requested.
• Manage Ipsen CDM training environment.
• Other administrative, operational assignments as requested.
• Trial / Study-related responsibilities
• Leadership / Management

Behavioural Competencies Required

Purpose Dedication Safeguards data integrity and patient safety. Ensures decisions and data strategies support ethical conduct, regulatory reliability, and inspection readiness. Promotes a consistent quality and compliance culture across internal teams and vendors.

Thinking Dexterity Connects study execution to asset and submission strategy. Anticipates risks affecting timelines, standards, and data flow, and implements mitigation plans. Uses metrics and trend analysis to improve data quality, efficiency, and processes, while introducing appropriate innovation and technology.

Social Agility Collaborates effectively across Clinical Operations, Biostatistics, Programming, Regulatory, and external partners. Influences in a matrix environment, manages challenging discussions constructively, and adapts communication to technical and non-technical stakeholders.

Growing Self and Others Leads, coaches, and develops Data Management staff. Sets clear expectations, provides feedback, and builds team capability in standards, quality oversight, and vendor management. Encourages ownership, learning, and knowledge sharing.

Being Intentional Operates effectively in ambiguity and changing development environments. Communicates decisions clearly, explains trade-offs, and escalates risks when needed. Maintains focus and resilience under delivery pressure.

Making Real Impact Delivers reliable, inspection-ready databases on time and within budget. Holds teams and vendors accountable to performance standards. Drives continuous improvement and contributes clear, data-based recommendations to program and submission decisions.

Knowledge & Experience (essential):

• Ability to manage large projects: plan activities and tasks, identify project constraints and dependencies, identify and mitigate risks, report on project status, produce progress metrics, and communicate efficiently with external vendors as well as internal stakeholders
• Ability to produce high quality, accurate work to meet deadlines
• Ability to interact satisfactorily with staff of differing disciplines
• Ability to work across organizational lines and geographies
• Well-developed time management, communication, presentation, analytical and interpersonal skills
• Responsible, flexible and accountable with a pro-active approach
• Experience of managing and developing relationships with Service Providers
• A good understanding of the drug development process
• Approximately 5-7 years of experience in a CDM leadership position with proven Project Management skills in Data Management activities at a development program level

Knowledge & Experience (preferred):

• High knowledge of international standards (ICH, GCP, CDISC ) and regulations related to clinical studies and data management
• Technical expertise in CDM systems
• Formal change management experience or certification
• Experience working across cultures and geographies
• Good budget management understanding

Education / Certifications (essential):

• Life Science and/or Information Technology graduate

Language(s) (essential):

• English

Language(s) (preferred):

• French