Non-CRO Vendor Strategy Director

WHAT - Summary & Purpose Of The Position

The Non CRO vendor director will be a critical contact for the Global Trial Lead (GTL) and the Cluster Trials Manager (CTM) and will be a primary IPSEN contact for vendors that provide a service across countries in a global clinical trial.

The role will be accountable for the development, endorsement and maintenance of IPSENs Non-CRO Vendor strategy.

The Non CRO Vendor Director will demonstrate effective cross functional management and will oversee the delivery of Non CRO vendors across the lifecycle of a trial.

The role supports inspection readiness by providing sponsor-oversight.

It will support cross-functional collaboration across Ipsen to identify and implement effective partnerships in support of clinical trial delivery.

The role will also foster long-term partnerships to optimize delivery and R&D spend across the portfolio.

Ensure selected non-FSP vendors support the smooth running of clinical trials at sites and support the speedy evolution of site issues.

WHAT - Main Responsibilities & Technical Competencies

The main responsibilities of the Non CRO vendor include

• Vendor Selection and Trial Delivery
• In partnership with procurement and the GTL, be accountable for selecting the right vendors for the services required and for overseeing the vendor performance and quality across the lifecycle of the study
• Develop a portfolio of collaborative high-performing relationships with non-FSP vendors
• At study start, ensure appropriate governance is established for all non-FSP vendors
• Support positive collaboration between FSP, sites and non-FSP vendors including as point of escalation to resolve issues
• Support integrated vendor planning across a TA and R&D portfolio to maximize operational and cost efficiencies
• Ensure the timely onboarding of vendors to support study delivery
• Governance
• Conduct business reviews with vendors to assess performance, capacity, risks, innovation opportunities, and continuous improvement initiatives.
• Ensure actions arising from governance meetings are documented, tracked, and closed within agreed timeline
• Establish and oversee structured escalation pathways for operational, quality, timeline, and compliance issues.
• Drive the establishment of performance metrics and continuous improvement
• Being a point of contact for issue escalation from the Non CRO vendor especially if the issue impacts the study globally
• Inspection Readiness
• Ensure vendor oversight plans, performance KPIs/reports, risk assessments, and issue logs are inspection-ready.
• Support regulatory inspections and internal audits involving outsourced activities.
• Contribute to Inspection Readiness activities as required
• Monitor operational, quality (including IR) risks associated with vendor performance
• Quality Management and CAPA
• Review, monitor, and oversee vendor quality events, deviations, protocol non-compliance, inspection findings, and CAPAs.
• Ensure root cause analysis and corrective actions are completed effectively and within agreed timelines.
• Escalate significant quality risks to CDO leadership and Global Quality as required.
• Vendor Performance and KPIs
• Define, implement, monitor, and report key performance indicators (KPIs) and key risk indicators (KRIs) for assigned vendors.
• Analyze performance trends and implement corrective and preventive actions where performance falls below agreed thresholds.
• Provide regular performance dashboards to study teams and senior stakeholders.
• Sharing routine reports and updates on the activities of the vendors as they relate to the trial to the GTL and/or CTM
• Support operational oversight of non-FSP vendors
• Vendor Risk management
• Lead vendor risk assessments throughout study startup, conduct, and closeout phases.
• Maintain vendor risk registers and ensure mitigation plans are implemented and monitored.
• Identify operational, compliance, financial, business continuity, cybersecurity, and capacity risks that may impact study delivery.
• Risk identification – proactively work with the Ipsen study team to identify and mitigate risks
• Budget Review
• Monitor vendors spend against budget and identify opportunities for cost efficiencies
• With Procurement and the GTL, review change orders, scope amendments, and financial impacts
• Study Close-Out
• Conduct end-of-study vendor performance evaluations and lessons learned review to contribute to continuous improvement.
• Drive lessons learned activities and ensure best practices are incorporated into future studies
• Other Responsibilities
• Retaining expertise in ICH GCP and country/cluster regulations
• Building and maintaining Intelligence on vendor services at a cluster/country level
• HOW - Behavioural Competencies Required
• Competency Description Competency Behavioural Markers

Excellence in Execution Planning and prioritizing work to meet commitments aligned with organizational goals. Consistently achieving results, even under tough circumstances.

• Approaches priority setting and setting the stage through the lens of execution.
• Establishes clarity about the goals, accountabilities, timelines, and next steps; can identify/spot opportunities for real impact on patient and society.
• Able to be focused and performance-driven with clear KPIs.
• Plans and aligns effectively (steps, resources, timelines etc.).
• Displays a commitment to best practice sharing and setting.
• Promotes single point of accountabilities.

Ensures Accountability Holding self and others accountable to meet commitments.

• Builds environment where people ask for clarification when accountabilities are unclear.
• Consults/seeks stakeholder views and ensures decisions are made by consent vs consensus.
• Takes personal accountability for decisions, actions, successes and failures.
• Follows through on commitment and makes sure others do the same.

Communicates Effectively Developing and delivering communications that convey a clear understanding of the unique needs of different audiences (GTLs and CSMs)

• Asks open questions and digs deeper; shows care and respect for different perspectives.
• Communicates transparently, tells it how it is while keeping communication respectful.
• Builds clear and crisp messages with structure and focus.
• HOW - Knowledge & Experience

Knowledge & Experience (essential)

• Demonstrated effective management of external vendors
• Demonstrated Project Management expertise
• Demonstrated extensive knowledge of ICH GCP
• Demonstrated ability to lead a cross functional matrix team when delivering a Clinical Trial
• Demonstrated ability to work cross countries/globally
• Demonstrated ability to work across Therapeutic Areas
• Knowledge & Experience (preferred)
• Experience in audit/inspection readiness, preparation and conduct. Experience of FDA or EMEA inspection preferred
• Preferred TA experience in Oncology, Rare Diseases or Neurosciences

Education / Certifications (essential)

• Batchelors Degree in life sciences or a professional degree in life sciences (eg Nursing, Pharmacy)
• Language(s) (essential)
• Fluent in English
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