TOX-Executive Director of Toxicology

POSITION SUMMARY: • Provide overall strategic and operational leadership management of Toxicology SD Team; • Ensure that a sufficient number of qualified personnel, appropriate facilities, equipment and materials are available for the timely and proper conduct of the study according to the master schedule; • Ensure that personnel, facilities, equipment, material and procedure are compliant with Protocols, SOP and GLPs; • Interact with other departments for matters related to the team to ensure proper conduct and reporting of studies; • Develop, review and approve the department SOPs and ensures GLP compliance; • Manages employee development, provides training, coaching and mentoring; • Guide the investigation and development of new capability and procedures; • Assign Study Directors, review and sign study protocols and reports KEY RESPONSIBILITIES: • Ensure that a sufficient number of qualified personnel, appropriate facilities, equipment and materials are available for the timely and proper conduct of the study; • Ensure the maintenance of a record of education, experience, qualifications, training and job description for each individual within the organization; • Ensure that personnel clearly understand the functions they are to perform and, where necessary, provide training for these functions; • Ensure that appropriate and technically valid standard operating procedures (SOP) are established and followed; • Ensure that quality assurance reports are addressed in a timely manner and corrective/preventative measures are documented and taken; • Ensure that individuals with the appropriate qualifications, training, and experience is designated by the management as the Study Director before the study is initiated. Replacement of a Study Director shall be executed and documented according to facility procedures; • Ensure documented approval of study protocol by the study director and that the study director has made the approval protocol available to the quality assurance personnel; • Ensure that there are clear lines of communication exists between the study director, principal investigator(s), the quality assurance personnel(s) and study personnel for a multisite study; • Ensure that, in the event of a multisite study, if needed, a Principal Investigator is designated, who is appropriately trained, qualified and experienced to supervise the delegated phase(s) of the study. Replacement of a Principal Investigator shall be executed and documented according to facility procedures; • Establish procedures to ensure that computerized systems are suitable for their intended purpose, and are validated, operated and maintained in accordance with the GLP regulations. • Periodic review (through TFM review meeting/trending report) of the facility system operations and study research to ensure its continuing suitability, adequacy and effectiveness, and make changes/ improvements if necessary. If authorized, as the backup person of facility head, be responsible for corresponding management and document signing.