About IpsenIpsen 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: Head of Feasibility and Study Planning
Division / Function: R&D – Clinical Development Operations (CDO)
Location: IPSEN Hubs – UK (London), France (Paris), USA (Cambridge, MA)
What - Summary & Purpose of the PositionTo lead and build Ipsen’s R&D global feasibility and study planning capability by establishing a predictive, data / insight driven, end-to-end planning model across the clinical development portfolio. The role is accountable for ensuring that all clinical studies are designed, assessed, and operationally planned with a high degree of rigor, leveraging data, analytics, insights from ISPEN/FSP staff using up-to-date ways of working e.g., AI-enabled to optimize timelines, cost, and probability of success.
What - Main Responsibilities & Technical Competencies- Define and implement Ipsen’s global feasibility and study planning strategy, aligned to the broader R&D and CDO transformation agenda.
- Build and lead a high-performing hybrid team (internal + FSP) delivering scalable and repeatable planning execution throughout the lifecycle of the trial.
- Establish governance, standards, and audit-ready processes for feasibility and planning outputs.
- Partner closely with appropriate groups across IPSEN e.g. R&D/Medical IT: Digital, Data, Analytics & AI to influence and shape technical solutions that meet R&D business needs.
- Oversee delivery of all planning components across the full lifecycle: study design input, feasibility assessment, site and PI identification, enrollment forecasting, and integrated operational plans.
- Ensure outputs from each step are integrated into a unified, data-driven operating plan.
- Lead development of quantitative feasibility dossiers balancing data-driven insights with expert insights from global and country study team representatives.
- Drive the utilisation and adoption of statistical models (e.g. Monte Carlo Simulations) with scenario planning.
- Ensure early integration of feasibility insights into protocol design to reduce amendments.
- Oversee development of data-driven country and site selection models based on patient availability, performance, and regulatory factors.
- Lead development of Site Activation and Enrollment forecasts using simulation models, incorporating key risk drivers.
- Build and maintain a centralized planning knowledge base, capturing lessons learned across trials.
How - Knowledge & ExperienceEssential:- 10-15 years experience in clinical trial feasibility, study design, and planning methodologies within global programs.
- 8+ years of experience in defining global strategy and driving global transformation.
- Proven experience leading data-driven clinical operations transformation initiatives.
- Experience managing hybrid delivery models (internal + FSP/CRO partners).
- Strong knowledge of real-world data and analytics applications in clinical development.
- Strong understanding of clinical systems (eTMF, CTMS, QMS, etc.) and business process design.
- Financial acumen is required.
Preferred:- Experience in Site Management and Monitoring optimal.
- Experience implementing AI/ML-driven planning or feasibility tools.
- Background in oncology and/or rare disease clinical development.
Education / CertificationsEssential: A minimum of a bachelor’s degree (University/college degree) in a scientific discipline or general management is required.
Preferred: Advanced degree (e.g., Masters, MBA, MD, PhD, Pharm D) is preferred.
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