- Provide leadership and medical expertise in the development of clinical research strategic programmes in line with global strategy and to support local product registration and marketing.
- Act as a medical resource to the company as a whole and particularly to the clinical research department (protocol and CRF writing, adverse events, discussions with investigators, and internal meetings).
- Work closely and cooperatively with research centres locally and overseas to ensure the Australian organisation contributes to the global development of new chemical entities.
- Develop clinical trial programmes to support product registration and marketing.
- Provide medical and scientific input to global product development teams.
- Provide medical expertise in the review of adverse experiences locally and contribute to global pharmacovigilance activities.
- Actively participate on Medicines Australia committees and analyse regular Medicines Australia correspondence with follow-up and discussion with internal colleagues and other industry participants on relevant issues.
- Establish ongoing liaison with key opinion leaders, government officials, TGA staff and healthcare organisations and ensure that significant developments in the field are identified and monitored.
- Represent the company at TGA discussions regarding the registration of new chemical entities.
- Provide the planning and leadership to the Medical department by ensuring that appropriate structures, systems, competencies and values are developed.
- Ensure that the interfaces between Medical and other departments are managed optimally.
- Form informal networks with company senior management, updating them on a regular basis on developments within Medical and progress made with the clinical and regulatory programme.
- In conjunction with local senior management develop strategic product plans whereby both new chemical entities and existing products are considered by Clinical, Regulatory, Marketing and Financial people through cross-functional teams, to ensure timely entry of new compounds to the market and the ongoing market success of existing products.
- Have responsibility for the financial management of the R&D programme including budget planning, resource allocation and preparation of quarterly reports.
- Work with clinical management to determine headcount requirements for clinical programmes, and be involved with the identification and selection of suitable candidates for positions.
- Ensure effective team communication throughout the department through the application of suitable reporting systems and structures and the identification and provision of appropriate training.