CDO Country Cluster Head - Cambridge, MA

Ipsen•Cambridge, MA

1d•$177,000 - $259,000•Onsite

About The Position

The Country-Cluster Lead is a leadership role, reporting to the Head of Study, Site Management and Monitoring (SSMM) within Clinical Development Operations. This role is 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.

Requirements

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.
A minimum of a Bachelor’s degree (University/college degree) in a scientific discipline or general management is required.
English

Nice To Haves

Experience including Early Development in Oncology (or in patients) preferred.
Advanced degree (e.g., Masters, MBA, MD, PhD , Pharm D) is preferred.
Country/Cluster languages preferred

Responsibilities

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.
Provide end‑to‑end oversight of FSP partners delivering: Country feasibility and site identification, Site selection and initiation, Study start‑up activities (including regulatory and contractual interfaces), Recruitment to agreed targets, Study, Site Management and Monitoring, Study close‑out and inspection readiness activities.
In country Study Management (CTM role).
With Business Enablement and Compliance, contribute to creation of a clear Study + Site Management and Monitoring Process Framework.
Ensure consistent application of Ipsen standards, SOPs, and quality expectations across all FSP‑delivered activities.
At cluster/country level, drive a strong partnership culture with FSP providers while maintaining appropriate independence and sponsor oversight.
Lead escalation and remediation of performance, quality, or compliance issues related to country or site‑level execution.
Act as senior IPSEN counterpart to FSP leadership within the cluster.
Influence and direct resourcing decisions and staff capability decisions at country/cluster level.
In collaboration with appropriate global functions, establish strategic, data‑driven approaches to country feasibility and site selection, ensuring optimal country and site choices.
Oversee site feasibility execution and validation to support realistic enrolment projections and operational planning.
Ensure efficient, compliant study start‑up execution, including: Site contracting and budget negotiations, Regulatory and ethics submissions (in partnership with applicable stakeholders e.g. Regulatory), Site initiation readiness.
Monitor start‑up performance metrics and proactively address delays or bottlenecks.
Implement risk‑based monitoring (RBQM) strategies in line with regulatory expectations and Ipsen standards. Ensure effective monitoring delivery across studies, including: On‑site, remote, and centralized monitoring activities, Investigational product compliance oversight, Source data verification, source document review and data quality oversight.
Partner with Data Management, Biostatistics, and Central Monitoring functions to ensure integrated oversight and risk mitigation. Drive consistency in site execution, issue management, and protocol adherence across all regions and studies.
Ensure timely and compliant study and site close‑out activities across Ipsen’s portfolio. Maintain continuous inspection readiness at site and country level, including oversight of: TMF completeness and quality (in collaboration with TMF leadership), Site documentation and essential document quality, Inspection preparedness activities with FSP partners and internal stakeholders.
Support country focused regulatory inspections and audits, acting as a senior sponsor representative for Study, Site Management and Monitoring matters.
At country/cluster level, own and implement Ipsen’s Site Engagement Strategy, aligned to clinical development priorities, therapeutic focus, and portfolio growth. Establish a structured approach to understanding Ipsen’s site landscape using it to lead the identification of priority and strategic sites, differentiating: High‑performing operational delivery sites, Emerging or development sites critical to pipeline growth, Sites in new/emerging Therapeutic Areas.
Be accountable for the health of investigator sites, including performance, recruitment/retention and quality.
Partner with key stakeholders (e.g. Local Medical Affairs)) to ensure that a robust, differentiated site engagement strategy is put into place. May include coordinating with global patient affairs to facilitate regional patient input into clinical trials. Own study level site segmentation strategy at country/cluster and, where necessary, will co-ordinate site segmentation plan for an asset globally.
Where appropriate partner with external groups like Patient Advocacy Groups to optimise access to subjects and to support site performance.
Understand the in-cluster capabilities and effectively communicate them to support the global strategy e.g. access to country specific registries, diagnostic testing pathways including planned policy changes.
Define, build, and grow the IPSEN internal Study, Site Management and Monitoring organisation. Overseeing the team of internal Cluster Trial Managers (CTMs) who will be responsible for Study Management within a cluster of countries and the Principal Clinical Research Associates. Partner with appropriate groups e.g. Training to ensure a highly skilled team focused on delivery.
Ensure all country level Study, Site Management and Monitoring activities comply with: ICH‑GCP, Applicable regional and local regulations, Ipsen SOPs, policies, and quality standards.
Embed proactive risk identification and mitigation at site and country level. Collaborate closely with Quality Assurance to address audit findings, CAPAs, and continuous improvement initiatives. Promote a culture of quality, accountability, and patient safety across internal teams and FSP partners.
Oversee a robust performance management framework for country level Study, Site Management and Monitoring activities.
Leverage operational, quality, and performance data to: Identify trends and risks, Drive evidence‑based decision‑making, Continuously improve efficiency and quality.
Deliver and continuously improve key country-level performance metrics (e.g. start-up timelines, recruitment rates, data quality, inspection outcomes).
Partner with Strategy and Operations and Business Enablement teams to enhance reporting and oversight capabilities (e.g. dashboards, KPIs). Champion innovation, digital enablement, and simplification across site‑level processes where appropriate.
Drives performance using data-driven insights, benchmarking, and targeted interventions at site and study level.
Lead and develop high‑performing internal, country/cluster teams and matrixed functions supporting Study, Site Management and Monitoring.
Support resource forecasting and management.
Act as a key interface with stakeholders across Clinical Development, Quality, Regulatory, Medical, and Global Operations.
Embody a culture of continuous improvement across the Site Management and Monitoring team.
Demonstrate leadership of change and be active in assuring change management practices are applied across the team.
Acts as a senior external ambassador for Ipsen, engaging with key health authorities, investigators, site networks, pharmaceutical associations, and institutional leadership to strengthen Ipsen’s industry reputation and access to high-value sites.