Beschreibung
We are currently recruiting for an Associate Director - Respiratory Clinical Development. You will be a board-registered Medical Doctor; specialising in Respiratory Diseases. Using your past experience in Clinical Development you will be responsible for the execution of scientific and medical strategy, medical and scientific monitoring, and reporting of quality data.We would welcome applicants from the US and other Home-based European applicants. You will be remotely managed therefore being home-based is a feasible option.
Responsibilities:
- You will provide clinical leadership, medical and scientific input, and contribute to the development of trial reports such as protocol, forms, data plans, publications etc. You will develop materials for trial-related advisory boards, data monitoring committees, investigator meetings, and protocol training meetings.
- Provide your medical and clinical input to the clinical sections of regulatory documents
- Ensure that medical support is accessible in the form of medical monitoring
- Conduct medical and scientific review of clinical trial data.
- Manage patient safety and reports on trial data to safety and clinical boards
- Provide input into final analyses and interpretation of the Clinical Study Reports
- Contribute to the overall safety of the compounds for different clinical trials in collaboration with Patient Safety
Requirements:
- Medical Doctor with advanced training in Respiratory Diseases.
- Ideally you will also have a Board certification
- Clinical Practice including residency, preferred.
- 3+ years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV.
- 2+ years of contribution to and accomplishment in all aspects of conducting clinical trials
- Excellent Knowledge in Respiratory Disease Area
- Demonstrated ability to establish effective working relationship with key investigators
- Working knowledge of good clinical practice, clinical trial design, statistics, and regulatory and clinical development processes
Please get in touch with Luchele Mendes
Michael Bailey International is acting as an Employment Business in relation to this vacancy.