TOX-Executive Director of Toxicology(J23303)

• 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.

• Advance degree (Ph.D.) in toxicology, pharmacology, pathology or related life sciences field
• At least 15+ years experience in GLP toxicology studes in CRO or pharmaceuticals;
• At least 10+ years management experience of toxicology scientists in CRO
• Expertise in regulatory guidelines (FDA, OECD) and data interpretation.
• Demonstrated leadership and excellent English written and oral communication skills;
• Certification in toxicology (i.e. DABT) is desired.