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.

Job Title: Director Operations - Clinical Data-Management (CDM)
Division / Function: Data Management, Standards & Systems / Clinical Development Operations
Location: Paris (FR), London (UK), or Boston (US)

Summary & Purpose of the Position
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.

Main Responsibilities & Technical Competencies
Non-trial, administrative operations responsibilities

• Define, implement, and oversee Quality Management (QM) within CDM, including creating a QM framework and working with QA on CAPAs and audit findings.
• Works collaboratively with Asset Data Management leaders and Talent Acquisition to identify and secure personnel resources through resourcing requirement models.
• Manages the CDM documentation environment such as Standard Operating Procedures (SOPs) and other working guidelines.
• Direct change management activities within CDM, establishing methodologies and promoting a change management mindset.
• Participate in operational governance with external partners, including KPIs/KQIs/metrics and innovation initiatives.
• Track, manage, and report on CDM KPIs, KQIs, and other metrics.
• Manage Ipsen CDM training environment and oversight of training compliance.

Trial / Study-related responsibilities

• Direct management of Ipsen CDM resources that are “pooled” across therapeutic areas including coding and data cleaning.
• Ensure study timelines and deliverables are met by team members with quality.
• Work collaboratively with Ipsen CDM leadership to ensure appropriate resourcing and study expectations.

Leadership / Management

• Responsible for the recruitment, talent development, line management and supervision of team members.
• Responsible for building capabilities and technical skills within his/her group.
• Member of the Ipsen CDM Leadership team.

Knowledge & Experience
Essential:

• Ability to manage large projects: plan activities, identify constraints, and mitigate risks.
• 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.
• Life Science and/or Information Technology graduate.

Preferred:

• High knowledge of international standards (ICH, GCP, CDISC) and regulations.
• Technical expertise in CDM systems.
• Formal change management experience or certification.

Nous nous engageons à créer un lieu de travail où chacun se sent écouté, valorisé et soutenu, où nous incarnons « The Real Us ». La valeur que nous accordons aux différentes perspectives et expériences motive notre engagement en faveur de l'inclusion et de l'égalité des chances.