At a Glance
- Tasks: Lead clinical pharmacy services and support innovative drug trials in oncology.
- Company: Ipsen, a global biopharmaceutical company focused on transformative medicines.
- Benefits: Inclusive culture, career growth, and the chance to make a real impact.
- Other info: Dynamic environment with a commitment to diversity and inclusion.
- Why this job: Join a passionate team dedicated to improving patient lives through innovative research.
- Qualifications: 7-10 years in clinical research, pharmacy degree, and oncology experience required.
The predicted salary is between 66150 - 80850 £ per year.
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 endeavour 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!
Job Description
Location: London, Paris, Cambridge MA
Summary & Purpose of the Position
The Clinical Research Pharmacy Services Lead serves as a pharmacy subject matter expert supporting Ipsen's 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.
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.
- 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.
Behavioural Competencies
- Strategic Leadership - Develops long-term capability strategies aligned with portfolio needs.
- Technical Expertise - Serves as recognized clinical trial pharmacy SME.
- Advanced Pharmacy Operations Expertise - Recognized expertise in investigational product handling, hazardous drug management, aseptic preparation techniques, and CSTD implementation.
- Collaboration - Builds strong internal and external partnerships.
- Communication - Translates complex pharmacy concepts into practical guidance.
- Innovation - Champions continuous improvement and modernization of pharmacy services.
- Accountability - Takes ownership for delivery of pharmacy support activities and service quality.
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.
- 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.
- Preferred
- Pharmacist licensure preferred.
Language(s)
- Essential
- English
- Preferred
- French
Company Culture & Commitment
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. At Ipsen, each employee makes a real impact. Our teams are passionate about what they do because they care about making a difference in patients’ lives. We invest in our employees to support life-changing projects that create positive impact for patients and society.
Clinical Research Pharmacy Services Lead employer: Ipsen Biopharm Ltd
Ipsen Biopharm Ltd is an excellent employer, offering a dynamic work environment in Wrexham where innovation and compliance are at the forefront of pharmaceutical manufacturing. Employees benefit from a strong commitment to health and safety, opportunities for professional growth, and a culture that values continuous improvement and teamwork. Joining Ipsen means being part of a dedicated team that plays a crucial role in delivering high-quality drug substances while enjoying the support and resources needed to thrive in your career.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Research Pharmacy Services Lead
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We think you need these skills to ace Clinical Research Pharmacy Services Lead
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Ipsen Biopharm Ltd!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Ipsen Biopharm Ltd that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Ipsen Biopharm Ltd!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Ipsen Biopharm Ltd, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Ipsen Biopharm Ltd
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Ipsen Biopharm Ltd that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Ipsen Biopharm Ltd’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
