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 company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!
For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.
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
Business Process Ownership
Clinical System’s
Training
Compliance
HOW – Behavioural Competencies Required
Competency
Drive Vision and Strategy
Excellence in Execution
Ensures Accountability
Communicates Effectively
Cultivate Innovation
Instils Trust
HOW – Knowledge & Experience
Knowledge & Experience (essential):
Sound financial acumen is required
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