Clinical Research Pharmacy Services Lead
Title:
Clinical Research Pharmacy Services LeadCompany:
Ipsen Biopharm LtdAbout Ipsen:
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.
Job Description:
POSITION
Job Title:
Clinical Research Pharmacy Services Lead
Division / Function:
Research and Development
Manager’s Job Title:
VP, Clinical Operations Oncology
Ipsen Job Profile:
Clinical Trial Operations
Location:
London, Paris, Cambridge MA’
WHAT - Summary & Purpose of the Position
The Clinical Research Pharmacy Services Lead serves as a pharmacy subject matter expert supporting IPSENs clinical development programs; particularly (although not exclusively) 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.
Working closely with Clinical Operations, Clinical Supply, Drug Product, Clinical Development, Quality, and external partners, the Senior Manager helps ensure study sites receive the education, resources, and support necessary to safely and compliantly manage investigational medicinal products.
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.
WHAT -Main Responsibilities & Technical Competencies
Clinical Trial Pharmacy Support
- 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.
Pharmacy Education & Training
- 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.
Hazardous Drug Handling & CSTD Expertise
- 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.
Quality & Compliance
- 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.
Vendor & Resource Oversight
- 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.
Process Improvement
- 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.
HOW - Behavioural Competencies Required
Strategic Leadership
- Develops long-term capability strategies aligned with portfolio needs.
- Anticipates future operational and regulatory requirements.
Technical Expertise
- Serves as recognized clinical trial pharmacy SME.
- Applies deep knowledge to solve complex operational challenges.
Advanced Pharmacy Operations Expertise
- Recognized expertise in investigational product handling, hazardous drug management, aseptic preparation techniques, and CSTD implementation.
- Ability to translate complex pharmacy requirements into practical operational solutions for global clinical trial sites.
Collaboration
- Builds strong internal and external partnerships.
- Influences across functions and organizational boundaries.
Communication
- Translates complex pharmacy concepts into practical guidance.
- Delivers clear, effective training to diverse audiences.
Innovation
- Champions continuous improvement and modernization of pharmacy services.
Accountability
- Takes ownership for delivery of pharmacy support activities and service quality.
HOW - Knowledge & Experience
Knowledge & Experience (essential):
- 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.
Knowledge & Experience (preferred):
- Experience supporting:
- Antibody-drug conjugates (ADCs)
- Biologics and innovative medicines
- Early Development Oncology
- Experience implementing or supporting CSTD programs.
- Experience working with global study teams.
- Experience managing FSP resources, vendors, or contractors.
Education / Certifications (essential):
- PharmD, MPharm, BPharm, or equivalent pharmacy degree.
Education / Certifications (preferred):
- Pharmacist licensure preferred.
Language(s) (essential):
- English
Language(s) (preferred):
- French
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