Madeleine Clarke

Madie has spent her career to date leading projects in regulatory affairs, clinical development and medical writing in the pharmaceutical industry. With extensive experience in the regulatory environments of Australia and New Zealand, Madie has worked on a wide range of medicines and medical devices across varying therapeutic areas, including pain, COVID-19, oncology and a number of orphan diseases.

Working with partners from around the world, Madie has collaborated on projects at all stages of a product’s lifecycle – from product development, clinical trials and dossier compilation, through to regulatory approval, commercialisation and post-market maintenance.

Having also led projects for the US, Canada, EU and Asia, Madie is adept at utilising knowledge of the global regulatory context to inform and optimise clinical, regulatory and commercial strategies for Australia and New Zealand. Most recently, Madie has been involved in a number of time-sensitive, fast-paced applications for prescription and biological medicines, including provisional and priority pathway applications, and agency work-sharing initiatives such as Project Orbis, in addition to providing strategic input into nonclinical and clinical development for early-stage advanced therapies.

Madie holds a BA/BSc from the University of Auckland and is based in New Zealand.