Clinical Supplies Specialist
Diurnal Ltd is an innovative UK-based specialty pharmaceutical company dedicated to developing high-quality hormone therapeutics to aid lifelong treatment for rare and chronic endocrine conditions, including Congenital Adrenal Hyperplasia, Adrenal Insufficiency, Hypogonadism and Hypothyroidism. Since our inception in 2004, our company mission has been clear: to address crucial unmet patient and clinical need in the endocrine field and deliver best health outcomes to improve patients’ quality of life. Diurnal has a strong, multi-skilled entrepreneurial management team with extensive pharmaceutical product development experience and an affiliated network of world-class clinical experts in endocrinology.
Location: Cardiff office (home-based may be considered)
- Diurnal has offices in Cardiff and London, the preference is for this role to be based in the Cardiff office with other permanent employees, however, working from home may be considered.
- The Clinical Supplies Specialist is responsible for the project management of Clinical Supply activities across all global programmes.
- Responsible for the project management and oversight of the GMP clinical supplies activities for all global programmes that the Company may develop, including liaison at third-party packaging CMOs and the sourcing of comparators where necessary in conjunction with the CMC Project Managers and Clinical Operations Project Managers.
The Clinical Supplies Specialist must be familiar with the following job requirements:
- Proactively manage the clinical supply of Investigational Medicinal Products (IMPs) and comparators for all Diurnal sponsored clinical studies from packaging CMO through to sites.
- Critically review the technical contents of the Clinical Supply work packages at third party manufacturers, ensuring compliance with the appropriate regulatory standards.
- Ensure that the Clinical Supply activities conducted at third-party packaging CMOs are executed in line with Diurnal’s agreed plans.
- Provide oversight to ensure that all out-sourced GMP activities under the scope of this role are performed in accordance with current Good Manufacturing Practices.
- Maintain a close working relationship with the Clinical Operations group and the Clinical Operations Project Manager (COPM) responsible for each study.
- Attend Clinical Study Team meetings as a fully integrated core member.
- Provide a regular update to the Clinical Team including Project Milestones, order (shipment) status and inventory levels across all products.
- Contribute to the development and review of Clinical Packaging, Clinical Trial Protocols and Clinical Labels.
- In conjunction with the CMC Project Manager manage the manufacture and supply of all IMPs for Diurnal’s clinical studies, including the sourcing/blinding of comparators.
- Demand Forecasting for Clinical Supplies including maintaining trigger levels and monitoring the expiry date.
- Working with the CMC Project Manager, COPM and Supply Chain Manager to maintain supplies, including IMP shelf-life extensions, returns and destruction.
- As applicable, liaise with Clinical CROs regarding (e.g.) IVRS systems.
- Administer the filing system for Diurnal’s Clinical Supply and CMC documentation.
- Participate in regular team meetings with the third-party packaging CMO and proactively manage the work plan using formal project management tools and organisational skills to manage activities in line with project needs.
- Review IMP shipping/distribution arrangements and make recommendations for efficiencies/enhancements.
- Review and approve quotations and supplier invoices.
- Maintain close awareness of evolving GMP and GCP requirements applicable to Clinical Supplies through regular review of published regulatory literature as well as through formal training.
- In conjunction with the CMC Project Manager and COPM, manage the QP/GMP release and shipment authorisation process for Clinical Supplies.
- In conjunction with the CMC Project Manager review and audit third party packaging CMO’s batch documentation (batch manufacturing records, deviations, quality control records, non-conformities and packaging/labelling records) as part of the batch disposition process.
- Adhere to Diurnal’s quality assurance system and compliance with the relevant SOPs, as well as review and approve Quality Deviations and dealing with CAPAs.
- Providing support and cover in the absence of members of the CMC team.
- Actively participate in Diurnal’s CMC Team Meeting and contribute to the development / growth of the CMC team.
- To promote continuous improvement in all aspects of the job.
- Life Sciences degree preferred, but not essential.
- Candidates with a minimum of 5 years’ relevant clinical trials supply experience in the pharmaceutical industry.
- Private Health
- Bonus Scheme