Medical Director

Job Description

  1. 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.
  2. 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).
  3. Work closely and cooperatively with research centres locally and overseas to ensure the Australian organisation contributes to the global development of new chemical entities.
  4. Develop clinical trial programmes to support product registration and marketing.
  5. Provide medical and scientific input to global product development teams.
  6. Provide medical expertise in the review of adverse experiences locally and contribute to global pharmacovigilance activities.
  7. 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.
  8. 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.
  9. Represent the company at TGA discussions regarding the registration of new chemical entities.
  10. Provide the planning and leadership to the Medical department by ensuring that appropriate structures, systems, competencies and values are developed.
  11. Ensure that the interfaces between Medical and other departments are managed optimally.
  12. 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.
  13. 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.
  14. Have responsibility for the financial management of the R&D programme including budget planning, resource allocation and preparation of quarterly reports.
  15. Work with clinical management to determine headcount requirements for clinical programmes, and be involved with the identification and selection of suitable candidates for positions.
  16. Ensure effective team communication throughout the department through the application of suitable reporting systems and structures and the identification and provision of appropriate training.