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About the Role
The Clinical Research Pharmacy Services Lead serves as a pharmacy subject matter expert supporting IPSENs clinical development programs, particularly in Oncology. The role is responsible for providing operational and technical expertise related to investigational product handling, preparation, administration, accountability, and pharmacy training activities across global clinical trials. This role supports increasingly complex therapeutic modalities, including biologics, antibody-drug conjugates (ADCs), and other innovative treatments, while contributing to the development of pharmacy-related processes, training programs, and best practices.
Responsibilities
- Serve as pharmacy subject matter expert on assigned clinical development programs and study teams.
- Review clinical protocols and provide recommendations regarding pharmacy feasibility, investigational product preparation, administration, storage, and accountability requirements.
- Support study startup activities by assessing pharmacy operational requirements and identifying potential risks.
- Collaborate with Clinical Operations and Clinical Supply teams to ensure successful implementation of pharmacy-related study activities.
- Support issue management and resolution related to investigational product handling and pharmacy operations.
- Develop and deliver pharmacy-related training to site pharmacists, research nurses, investigators, and study teams.
- Create and maintain pharmacy manuals, guidance documents, job aids, and training materials.
- Support site onboarding and readiness activities by providing pharmacy-focused education and consultation.
- Evaluate training effectiveness and identify opportunities for improvement.
- Provide expertise related to hazardous investigational product handling and preparation.
- Support implementation and appropriate use of Closed System Transfer Devices (CSTDs) in clinical trials when required.
- Advise study teams and sites regarding USP <800>, NIOSH, ISOPP, and applicable regional requirements.
- Advise Drug Product on common CSTD used by clinical sites to promote proactive compatibility testing for new assets in development.
- Assess site capabilities and readiness for studies involving hazardous compounds and advanced therapies.
- Support development of standards and guidance related to safe handling practices.
- Ensure pharmacy-related activities are conducted in accordance with applicable GCP, GMP, quality standards, and regulatory requirements.
- Support inspection readiness activities and participate in audits and inspections as needed.
- Contribute to the development and maintenance of pharmacy-related procedures and best practices.
- Assist in the investigation and resolution of pharmacy-related deviations and CAPAs.
- Manage day-to-day activities of assigned FSP Clinical Research Pharmacists or pharmacy contractors.
- Monitor performance and deliverables of external pharmacy vendors.
- Contribute to workload planning and resource forecasting.
- Ensure consistent delivery of pharmacy support across assigned studies.
- Identify opportunities to improve pharmacy support models, training programs, and operational processes.
- Contribute to implementation of new tools, technologies, and innovative approaches supporting investigational product management.
- Share best practices across study teams and therapeutic areas.
Requirements
- Approximately 7-10 years of experience in pharmaceutical, biotechnology, CRO, academic medical center, or clinical research settings.
- Experience supporting clinical trials involving investigational medicinal products.
- Experience within Oncology clinical research.
- Experience developing and delivering pharmacy training and educational materials.
- Knowledge of investigational product management and site pharmacy operations.
- Experience of approximately 3-5 years as a clinical site pharmacist in the hospital setting.
- Experience supporting Antibody-drug conjugates (ADCs).
- Experience supporting Biologics and innovative medicines.
- Experience supporting Early Development Oncology.
- Experience implementing or supporting CSTD programs.
- Experience working with global study teams.
- Experience managing FSP resources, vendors, or contractors.
Skills
- Clinical Trial Pharmacy Support
- Pharmacy Education & Training
- Hazardous Drug Handling & CSTD Expertise
- Quality & Compliance
- Vendor & Resource Oversight
- Process Improvement
- Strategic Leadership
- Technical Expertise
- Advanced Pharmacy Operations Expertise
- Collaboration
- Communication
- Innovation
- Accountability
Location
- London
- Paris
- Cambridge MA
Work Type
- Hybrid
Experience Level
- 7-10 years of experience
- 3-5 years as a clinical site pharmacist
Education Level
- PharmD, MPharm, BPharm, or equivalent pharmacy degree.
- Pharmacist licensure preferred.
About the Company
- Ipsen 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.
- Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries.
- We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact.
- At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success.
- Join us on our journey towards sustainable growth, creating real impact on patients and society!
- For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.
Equal Opportunity
- We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”.
- The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities.
- When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions.
- Together we strive to better understand the communities we serve.
- This means we also want to help you perform at your best when applying for a role with us.
- If you require any adjustments or support during the application process, please let the recruitment team know.
- This information will be handled with care and will not affect the outcome of your application.