The role of Director Clinical Research provides medical/clinical input into the development and/or commercialization of AZ compounds by integrating detailed disease area knowledge into design of drug registration programs and diligence reviews of licensing candidates. Therapy area research physicians are involved in all aspects of the design, conduct, monitoring, interpretation, and reporting of clinical trials as well as regulatory and safety post-marketing support This individual must ensure that all clinical studies operate to the highest ethical and safety standards in compliance with GCP and regulatory requirements.
The ideal candidate would have clinical development experience in the area of neurological and/or psychiatric diseases. This would include regulatory interactions/filings/approvals and approval of promotional material. Content expertise in Alzheimer's disease, Depression, Schizophrenia, Anesthesia or MS is desirable. Overall, preference will be given to individual with an interest and high potential to develop into a medical leader capable of working in any GMED disease area.
The role holder can expect, in general, to be working in global R&D teams interacting regularly with other therapeutic areas and functions outside of clinical to ensure that the medical tactics for the compound under development are appropriate to the overall development strategy.
Individuals with limited Pharmaceutical Experience are welcome to apply and may qualify for Associate Director or Director level depending experience, expertise and capabilities.
Work will be varied and may include:
1. Provide clinical contribution to creation of Target Product Profiles, Target Product Claims Document, & comprehensive Clinical Development Plans
2. Lead planning, execution, and interpretation of phase IIB-IV clinical trials
3. Lead and contribute towards regulatory communication and preparation of higher level clinical submission documents
4. Lead investigator meetings, advisory boards, etc.
5. Provide medical input to commercial activities including the planning, preparation of promotional material, commercial training materials and presentations.
6. Develop and maintain relationships with external experts and healthcare professionals
1. Support evaluation of major external collaborations or in-licensing opportunities
2. Supervise junior role holders and other scientific colleagues
Requirements --Education and Experience
- Medical doctor with specialty training and board certification in adult neurology or psychiatry is preferred. Candidates with a General Medicine Background will be considered with demonstration of appropriate experience or relevant background (e.g. geriatrics, clinical research in relevant disease area).
- Greater than 3 years of drug development /commercialization experience (the majority of which should be in industry) and/or a clear potential to grow into senior medical role.
- Ability to balance business and clinical research objectives is critical
- Thorough understanding of pharmaceutical safety reporting and surveillance processes
- Experience working with regulatory agencies and preparing regulatory documents
Skills and Capabilities
- Strong team-working skills and an ability to work in a global pharmaceutical environment
- Strategic thinking
- Strategic influencing
- Foster behaviours that reinforce AZ as a global organization
- Ensure respect for different practices and expertise in different environments
- Passion for Customers
- Thinks Strategically
- Acts Decisively
- Drives Performance
- Works Collaboratively
- Develops People and Organization
Please apply here: http://www.hirelifescience.com/seeker_jobs.aspx?jobsID=429401&jobtitle=Director Clinical Research- Neuroscience