Therapy Area Development Teams

Three cross functional teams are staffed by Clinical Development, Regulatory Development and Project Management professionals who integrate their activities in order to co ordinate all activities relating to the conduct of interventional clinical studies.

The teams are lead by a Therapy Area Director who is responsible for the leadership of the projects under their team and the allocation of resources both from within their team and in other departments whose contribution is essential for successful delivery of projects. Therapy Area Teams also take a lead on the technical evaluation of the company’s business development activities, when products with potential for in-licensing are assessed and where expert understanding of the drug development process is required.  Although Norgine outsources the majority of clinical trials to specialist service providers, the in-house staff retain oversight of the trial process and form the key liaison to the rest of Norgine, ensuring that patient safety, data quality, scientific validity and the integrity of the trial is maintained throughout by adhering to the principles of Good Clinical Practice, local legislation and guidelines.   The Regulatory staff within the Therapy Area Teams is key in managing our liaison with Regulatory Authorities and in ensuring that regulatory requirements are built into our overall development strategies. They lead on regulatory interactions and provide guidance on how best to deliver against authority expectations. The Regulatory staff also works closely with manufacturing and supply to ensure that all elements of CMC come together to support the development, registration and launch of a drug product with optimal quality.  

The Project Management staff are responsible for collation and management the overall development plan. This includes all activities required to take a project from early development through to successful registration. Developing an integrated plan and providing input to ways to deliver it more effectively are key requirements from these staff.