Clinical Research Pharmacy Services Lead

Ipsen Biopharmaceuticals Inc.; Greater London; On-site; GBP 90,000 - 130,000; Full time

Job summary

Ipsen Biopharm Ltd is seeking a Clinical Research Pharmacy Services Lead to provide expert pharmacy leadership for investigational products in global clinical trials. The role supports oncology programs with operational and technical guidance on handling, preparation, storage, and accountability of investigational products.

You will partner with Clinical Operations, Drug Product and Quality teams to ensure safe, compliant trial execution.

Responsibilities

• Provide pharmacy domain expertise to support IPSEN's clinical development programs, especially in Oncology.
• Review protocols and advise on pharmacy feasibility, product preparation, storage, and accountability.
• Support study startup by assessing pharmacy operational requirements and risks.
• Collaborate with Clinical Operations, Clinical Supply and other teams to implement pharmacy activities.
• Address issues related to investigational product handling and pharmacy operations.

Job description

Clinical Research Pharmacy Services Lead

Title: Clinical Research Pharmacy Services Lead

Company: Ipsen Biopharm Ltd

About 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 , 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 process