Would you like to utilise your supply chain knowledge and skill base to lead clinical supplies for your portfolio of global clinical studies? The Clinical Supply Study Lead (CSSL) is a key role within our Clinical Manufacturing and Supply teams. This role involves running a portfolio of studies across all phases of a drug development programme ensuring on time delivery to patients. We have opportunities to join the Clinical Supply Team on either a Permanent Contract, or 12 Month Secondment / Fixed Term Contract, basis.
What you'll do
Project manage the delivery of clinical supplies effectively and consistently, and input to the balance of costs and any risks to supply, following defined business processes
Lead the Study Drug Working Group and contribute to the Supply Chain Team Meetings enabling continuous cross-functional dialogue with both internal and external partners on study design requirements and associated changes which may impact the supply chain elements of the study
Work within GMP Quality Management Systems ensuring that you actively handle any deviations, complaints and change controls
Understand customer demand requirements and have the ability to translate this into a supply plan
Manage the Interactive Response Technology (IRT) system to execute demand and supply planning
Take ownership for Inventory management, utilising systems such as Smart Supplies, including any rework and recalls, extensions of shelf life and expiry date management, or stock destruction
Ensure effective communication with project teams and key partners across a global network
Support risk management of individual studies with proactive mitigation of risks that potentially impact the quality or delivery of supplies, ensuring consistent on time delivery of drug to patient
Monitor the budget for your individual study supply activities and materials for the project including packaging, labelling and distribution costs
Bachelors Degree in a scientific or business subject area – equivalent experience will be considered
Experience within a supply chain environment or pharmaceutical industry
Holistic knowledge of end to end supply chain activities
Experience and proven track record of successful demand and supply planning
Experience in running projects and influencing customer demands
Analytical aptitude, showing strong data analysis skillbase and ability to utilise dashboards
Strong influencing, negotiating and problem-solving skills, across geographical and cultural boundaries
Risk identification and management
LEAN capabilities
Excellent English written and verbal communication skills
Proficient IT skills with an ability to adapt and operate in bespoke multiple systems
Desirable Skills & Knowledge
Awareness of GMP (Good Manufacturing Practise) and GCP (Good Clinical Practice)
Knowledge of clinical development processes relevant to the supply of clinical materials
Experienced in handling Quality Events (Deviations, Change Controls, Complaints)
Use of either SmartSupplies or SAP would be an advantage
Good working knowledge of planning applications