Life Sciences & Technology
| Clinical Research & Clinical Affairs
A BDN client is looking for a Clinical Operations Director to execute end-to-end operationalization and implementation of clinical protocols from CRO selection through clinical site start-up, clinical sample handling and processing oversight at the sites, shipping, and management at CROs or academic collaborators. Data management through to database lock and study closeout for all development programs in accordance with company policies and SOPs, FDA and ICH guidelines, and applicable regulations is essential. The consultant will develop clinical operations, data management, and clinical sample management strategies for clinical program execution. Partnering with clinical colleagues on the selection of investigators / clinical sites, and CRO/vendors are desired. Experience working in small companies, or an appreciation of and desire to work in a small company environment (small team and needs to be comfortable working in a smaller company with less structure, processes, and resources as larger companies) is preferable. A clear understanding of the components of the clinical drug development pathway from IND preparations, first in human, clinical proof of concept, registration directed pivotal trials through to NDA filing, and the necessary interdependency of these components. Previous experience as a Director of Clinical Operations, and display a high degree of accountability, be very hands-on, and can move/drive projects forward is ideal for this position.