Associate Medical Director

Job Description

1. Overall medical management of the Phase II-IV clinical trial programme including handling medical enquiries, investigator selection, protocol and CRF preparation, investigator management, adverse event monitoring and report writing.
2. Ensure that all aspects of GCP are complied with at all times through provision of training at start-up and initiation meetings for clinical trials and on-going SOP development.
3. Prepare assessments outlining the capability of the local organisation to contribute to global clinical trial programmes. This will involve: an analysis of local patient numbers and key investigators for each therapeutic area, determination of any specific inclusions in the global protocols for later health economic reasons, preparation of research budgets, and discussions with potential investigators.
4. To work closely and cooperatively with corporate research centres to ensure Australia contributes to the global development of clinical research.
5. Work with local management to develop plans for phase IV clinical trials for registered products. These trials will focus on obtaining appropriate local data to support subsequent marketing activities.
6. Provide medical input to global product development teams.
7. Provide medical expertise in the review of adverse experiences locally, discuss patient management issues with investigators and contribute to global pharmacovigilance activities.
8. Conduct training sessions for CRAs and sales representatives on ADR reporting and the importance of pharmacovigilance.
9. Represent the company via presentations to groups of experts, societies, regulatory bodies and at international meetings ensuring that the professional standing of the company is enhanced.
10. Provide medical assistance with the preparation and discussion of submissions to regulatory agencies, reimbursement applications, hospital formularies and tender documents.
11. Form informal networks with company senior management, updating them on a regular basis on developments within Medical and progress made with the clinical programme.
12. Participate in strategic planning in a multidisciplinary setting involving clinical, regulatory, marketing and business development interests.
13. Financial management of the research programme including budget planning, resource allocation and preparation of quarterly reports.
14. Work with marketing to ensure that the medical content of all promotional material is correct, fully supported by the Product Information and literature, and in accordance with the guidance offered by the Medicines Australia Code of Conduct.
15. Marketing support including customer meetings, presentations, promotional material, representative training, market research and product launches.
16. Training Sales Representatives and Clinical Research Associates, and other relevant personnel in the principles and practices of disease management for nominated therapeutic areas.
17. Training of Clinical Research Associates in GCP principles and procedures and product characteristics.
18. Coaching of Project Managers in various aspects of management (eg HR issues, budgets, resource allocation).