Clinical Supply Planner
Essential Pharma are looking for a Clinical Supply Planner to join us! This role will include determining packaging, labelling requirements for clinical trial supplies, inventory control of distributed clinical trials supplies in line with clinical demand at sites, cold chain storage at local warehouses and clinical trial sites according to GCP and worldwide distribution requirements for export/import of the study drugs being trialed. Strict compliance with national and international regulation and manufacturing practices (GCP/ GDP) and appreciation of GMP standards is essential at all stages of the supply chain to meet the clinical demand. Apply today!
What You Will Do
- Provide and manage the clinical demand to manufacturing project management based on clinical development plan to allow manufacturing sourcing and lead times.
- Work closely with the clinical manager to establish the needs for the IMP as per study protocol and territories.
- Collaborate with the manufacturing Development Project Manager for the clinical demand from forecasting according to recruitment strategies to delivery of supplies to clinical sites through coordination of resources, managing risk progressively throughout the life cycle of the project.
- Drive the project schedule and associated deliverables by working with internal/external stakeholders in clinical development i.e. Project managers for clinical and manufacturing development.
- Liaising with both managers to marry up the need for labelled and packaged supplies available and the demand at the sites/ territories to avoid stock outs in ongoing trials
- Serve as the primary point of contact and initial escalation point for all internal/external project challenges related to clinical trials supplies at sites/ territories.
- Hold full responsibility for the timely delivery of projects through successful coordination of all tasks associated with company deliverables.
- Assess scope, timing and operational requirements of the project
- Key contact for establishing site by site destruction/ returns strategies for the trial and ensure documented.
- Ensure documentation for supplies are filed appropriately as Essential Records according to GCP/ TMF planning etc.
- Maintain inventory of IMP
- Facilitate transfers from site to site as needs be and oversee the shipments.
- Ensure essential records in place following regulatory green light and are applicable for the territories and the clinical trial protocol.
- Notify the Manufacturing PM of any deviations affecting product quality and provide appropriate supportive documentation to allow a review and facilitate any product recall/ quarantine etc.
- Contribute to SOP compilation relating to clinical demand at site.
- Create and implement Standard Operating Procedures (SOPs) for all aspects of the clinical trial demand.
- Contribute/ drive to the distribution plan/ labelling text/ translations to enable manufacturing PM to plan the GMP production of labelled and packaged supplies manufacturing.
- Establish clear communication pathways to define roles and responsibilities, and to ensure accurate and timely exchange of information to support development of supply chain strategies, including forecasting in respect to clinical recruitment and according to the study protocol.
- Critically evaluate available information and provide advice to create a robust and flexible supply chain strategy that ensures drug availability but also minimizes waste at sites.
- Ensure a valid Technical Agreement (TA) is in place to document standard working practices and define responsibilities, as applicable.
- Lead the coordination of activities of other company business units involved in the project, where applicable, ensuring expectations are understood by all parties. Work with third parties involved in projects such as CROs and/or consultants.
- Ensure the optimal set up and ongoing maintenance of the Interactive Response Technology (IRT) System in support of medication management, where contracted and as applicable.
- Oversee the clinical demand to lead planning for clinical trial supplies (in line with study protocol) and distribution plans. Maintain forecasts on an ongoing basis, adapting strategies as required to minimize product wastage and assure site supply needs are met.
- Prioritise, troubleshoot and assist with identifying and solving clinical supply issues. Monitor inventory levels of product at all depots and clinical sites.
- Perform risk assessment at project initiation and continually assess throughout the project. Work together with the project team and internal departments to prioritize and mitigate any project risks identified.
- Monitor budgets, ensuring projects are proceeding in line with approved quotations for distribution to the clinical sites.
- Ensure any trends in quality issues reported are identified and actioned accordingly to the project team and acted upon via CAPA
- Monitor and advise upon receipt of product related temperature excursions both in-transit and at sites in a timely manner and ensure communicated to PM Manufacturing Dev
What We Do
Essential Pharma is an international specialty pharmaceutical company dedicated to maintaining access to clinically differentiated, niche medicines in small patient populations. Our high-impact portfolio includes over 300 medicines covering ten therapeutic areas, with a focus on the central nervous system (CNS), gastroenterology, ophthalmology, and rare diseases. Our products treat patients in more than 70 countries.
We are proactive in identifying low volume, difficult-to-manufacture therapeutic products, and late-stage clinical development assets that target rare diseases. Our recent acquisition of Renaissance Pharmaceuticals is a significant milestone for Essential Pharma, the groups second product for treatment of a rare disease, and the first development-stage asset in our portfolio.
In December 2024, Essential Pharma announced a €900 million recapitalisation with partners Gyrus Capital, welcoming AlpInvest and new strategic financing from Sixth Street.
Our business is comprised of around 70 people based out of our offices in Surrey UK, Malta, France, Spain and Switzerland.
What You Will Bring
- Significant in a pharmaceutical industry in a Supply Chain function, preferably with significant exposure to clinical trials and supplies.
- Experience in previous clinical trials with multi-territories and multi-sites is a requirement as well as involved in label design for multi-language countries and subject kit design. Additional experience in sourcing and supply of non-IMPs and ancillaries to support a trial.
- High level understanding of critical GXP, GCP project documentation and their relevance to the project plan and ensure are filed correctly in accordance with the established project filing i.e. TMF etc.
- Experience of working with ERP systems.
- Evidence of effective communication and stakeholder management.
- GDP, GCP and GMP proficiency.
What We Offer
- Competitive Salary
- Hybrid Working: We offer flexibility and trust from day one, with a balance of remote and office-based work. We understand that different roles have different requirements and are committed to providing additional flexibility as needed. This will be discussed during the initial interview process.
- £150 towards your home office – claim purchases back on expenses.
- Healthcare Insurance
- Pension – you contribute 5% and we offer 5%.
- Life Insurance – lump sum (tax free) death benefit of 4 x basic salary.
- Enhanced Family Leave
- Enhanced Sick Pay
- Annual Leave – 26 days
- Discretionary Annual Performance Bonus
What To Expect
- We wholeheartedly embrace agile and hybrid working, recognizing that it enables individuals to bring their authentic selves to work. Our commitment to living by our values forms the bedrock of our inclusive culture, where everyone's voice is valued and respected.
- Treating each other as adults fosters a sense of autonomy and responsibility, while our inherent social nature is nurtured through engaging groups and events. We understand the significance of forging connections in the workplace, and our dedication to facilitating these bonds is underscored by regular access to our CEO. Grounded in the principles of dynamism, responsibility, trustworthiness, and collaboration, our values guide our interactions. Furthermore, our unwavering dedication to employee growth and learning is evident through our commitment to personalized development plans, as we believe in fostering an environment where all individuals can thrive.
- Right from the interview stage, we encourage candidates to ask us questions, as we understand that it's just as important for us to be the right fit for you as it is for you to be the right fit for us.
