Overview
As Clinical Research Pharmacy Services Lead, you apply pharmacology expertise to support Ipsen’s clinical development programs, especially in Oncology, ensuring safe, compliant handling of investigational products across global trials. You’ll partner with Clinical Operations, Supply, and Quality to enable site readiness, training, and process improvements. You’ll shape pharmacy best practices for complex modalities like biologics and ADCs, delivering education and overseeing external pharmacy resources. This role offers scope to impact trial execution and patient safety at scale.
Responsibilities
- Serve as the pharmacy SME on assigned development programs and study teams
- Review protocols to advise on feasibility, preparation, storage, and accountability of investigational products
- Support study startup by assessing pharmacy requirements and risks
- Collaborate with Clinical Operations and Clinical Supply to implement pharmacy activities
- Support issue management related to investigational product handling
- Develop and deliver pharmacy training to site staff and study teams
- Create and maintain pharmacy manuals, job aids, and training materials
- Support site onboarding with pharmacy education and consultation
- Evaluate training effectiveness and identify improvement opportunities
- Provide expertise on hazardous drug handling and CSTDs
- Advise on USP , NIOSH, ISOPP, and regional requirements
- Assist Drug Product with CSTD compatibility testing for new assets
- Assess site readiness for hazardous compounds and advanced therapies
- Support development of safe handling standards and guidance
- Ensure pharmacy activities comply with GCP, GMP and regulatory requirements
- Assist audits, inspections, and CAPA investigations
- Oversee day-to-day activities of assigned pharmacists or contract resources
- Monitor external vendor performance and deliverables
- Participate in workload planning and resource forecasting
- Identify and implement process improvements in pharmacy support models
- Contribute to adoption of new tools and technologies in DP management
- Share best practices across study teams and therapeutic areas
Key requirements
- 7–10 years in pharma/biotech/CRO/clinical research settings
- Experience supporting trials with investigational medicinal products
- Oncology clinical research experience
- Experience developing and delivering pharmacy training materials
- Knowledge of investigational product management and site operations
- Approximately 3–5 years as a clinical site pharmacist in hospital settings
- Strategic leadership
- Collaboration and relationship-building
- Clear and practical communication
- Advanced pharmacy operations in clinical trials
- Hazardous drug handling and CSTDs
- Aseptic preparation techniques
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