CDO Country Cluster Head - London

Title:

CDO Country Cluster Head - London

Company:

Ipsen Biopharm Ltd

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.

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 foster 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.

Job Description:

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The Country-Cluster Lead is a leadership role, reporting to the Head of Study, Site Management and Monitoring (SSMM) within Clinical Development Operations, accountable for the oversight and operational excellence of Ipsen’s Country Operations activities under a Functional Service Provider (FSP) delivery model. The role provides leadership across the clinical trial lifecycle at country and site level, from feasibility and site selection through study start-up, site management, monitoring (inc Risk Based), study close-out, and inspection readiness.

The role ensures consistent, compliant, and high-quality execution at country level IPSEN studies in the CDO portfolio and will be accountable for governance, and oversight of FSP partners delivering country and site-level activities on Ipsen’s behalf. The individual will require a 'Think Local, Act Global' mindset understanding local needs, within their Country/Cluster, but an ability to think strategically and to align globally.

The role is accountable for ensuring high-performing sites, reliable data, and effective, best in class investigator relationships across Ipsen’s global portfolio. Acts as single point of accountability for country/cluster level performance.

The Country-Cluster Lead manages IPSEN staff, operating within that Cluster including Functional Managers, Cluster Trial Managers and Principal Clinical Research Associates. They also collaborate closely with FSP Leadership and Staff in their Cluster/Country.

Trial Delivery

• Partner with functional leaders and FSP partners to ensure clinical trials are delivered on time, within budget, and in-line with Quality standards.

• Overall accountability for country(s) project delivery to agreed timelines, including patient recruitment targets.

• Build, develop and motivate a high-performing internal team and ensure FSP providers are bringing the right resource on board to ensure overall delivery.

• Drive continuous improvement of Clinical Operations processes and procedures to optimise development speed, quality, quality and regulatory compliance

Functional Service Provider (FSP) Oversight & Governance

• Provide end-to-end oversight of FSP partners delivering:

Knowledge & Experience (essential):

• A minimum 10 years experience in Clinical Trials

• Demonstrated experience leading Country Operations teams of different sizes and operational models across all trial types. Experience in Site Management and Monitoring required

• Demonstrated experience of people/project management experience, (e.g., leading project teams, operational teams, cross functional teams through operational change and transformation).

• Extensive experience in clinical development, clinical operations, quality, compliance, or related areas in the pharmaceutical or biotech industry.

• Demonstrated 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. Track record of managing FDA/EMA inspections.

• 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.

• 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

• Financial acumen is required

Knowledge & Experience (preferred):

• Experience including Early Development in Oncology (or in patients) preferred.

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 , Pharm D) is preferred.

Language(s) (essential):

• English

We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace "The Real Us". The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application.