At a Glance
- Tasks: Lead global feasibility and study planning for innovative clinical trials using data-driven strategies.
- Company: Ipsen, a forward-thinking R&D company focused on transforming healthcare.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Join a diverse team committed to innovation and continuous improvement.
- Why this job: Make a real impact in clinical development while working with cutting-edge technology.
- Qualifications: 10-15 years in clinical trial planning and strong leadership skills required.
The predicted salary is between 60000 - 80000 £ per year.
- Head of Feasibility and Study Planning
- Summary & Purpose
Lead and build Ipsen’s R&D global feasibility and study planning capability by establishing a predictive, data‑driven, end‑to‑end planning model across the clinical development portfolio.
The role ensures all clinical studies are designed, assessed, and operationally planned with rigor, leveraging analytics, AI, and insights to optimize timelines, cost, and probability of success.
- Main Responsibilities
- Define and implement Ipsen’s global feasibility and study planning strategy in alignment with R&D and transformation agenda.
- Build and lead a high‑performing hybrid team (internal + FSP) to deliver scalable, repeatable planning execution throughout the trial lifecycle.
- Establish governance, standards, and audit‑ready processes for feasibility and planning outputs.
- Partner with R&D, Medical, IT, Digital, Data, Analytics & AI to shape technical solutions and influence operational planning.
- Own IPSEN R&D Clinical Trial Footprint and support feasibility for Medical Affairs studies.
- Oversee delivery of all planning components: study design input, feasibility assessment, site and PI identification strategy, enrollment forecasting, and integrated operational plans.
- Apply quantitative feasibility dossiers, using disease epidemiology, real‑world data, eligibility modelling, competitive landscape, and statistical simulations.
- Drive advanced analytics integration, including cohort analytics, AI‑driven site and patient intelligence, predictive enrollment, and simulation modeling.
- Support protocol design with feasibility insights, optimize inclusion/exclusion criteria, endpoints, and study complexity.
- Develop country and site selection models based on patient availability, regulatory factors, site performance, and diversity.
- Lead Site Activation and Enrollment forecasts, incorporating risk drivers and translating into operational strategies.
- Maintain a centralized planning knowledge base and promote continuous improvement, defining KPIs for effectiveness.
- Knowledge & Experience – Essential
- 10–15 years in clinical trial feasibility, study design, and planning methodologies within global programs.
- 8+ years defining global strategy and driving transformation.
- Proven experience leading data‑driven clinical operations transformation initiatives.
- Experience collaborating with Country Operations and managing hybrid delivery models.
- Strong understanding of real‑world data, enrollment forecasting, site selection, and process optimisation.
- Project management excellence and ability to influence at a global, cross‑functional level.
- Financial acumen and knowledge of clinical systems (e TMF, CTMS, QMS).
- Knowledge & Experience – Preferred
- Site Management and Monitoring experience.
- Implementation of AI/ML‑driven planning or feasibility tools.
- Background in oncology and/or rare disease clinical development.
- Experience with CTMS/data platforms and integrated data environments.
Education & Certifications – Essential
- Bachelor’s degree in a scientific discipline or general management.
Education & Certifications – Preferred
- Advanced degree (Master’s, MBA, MD, Ph D, Pharm D).
- Language
- English (required)
- Equal Opportunity Statement
We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us” and strive to better understand the communities we serve.
This commitment to inclusion and equal opportunities is fundamental at Ipsen.
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