The Associate Director, Clinical Trial Management/Operations is responsible for leading the Clinical Trial Management (CTM) group which includes Clinical Trial Managers, Clinical Research Associates, Field CRAs, and Clinical Trial Associates. This position will take the lead role in managing the day to day operations of the CTM group, as well as a strategic role in creating and implementing robust clinical trial programs. This position will have responsibility for the oversight of clinical trials across all studies within Seattle Genetics.

RESPONSIBILITIES:
- Determine the best utilization of CTM resources, and the optimal organization of the CTM infrastructure and staff.
- Along with the Director of Clinical Operations, establish a strategic vision and long-range plan for the CTM function.
- Responsible for developing and maintaining SOPs and training guides applicable to a global organization.
- Ensure consistency and best practices are followed on all processes, protocols, and within the Clinical Trial Management System (CTMS).
- Take a lead role in managing projects and collaborating across departments such as drug supply, regulatory, data management, biostatistics, medical writing and drug safety.
- Provide CTM staff with appropriate coaching, mentoring and development.
- Make decisions on selecting and managing CTM staff as well as external field contractors.
- Ensure proper training is implemented to demonstrate to demonstrate CFR, GCP/ICH compliance.
- Responsible for quality control plan for the clinical trials site monitoring and management, both for the external field staff and within the internal CTM staff.
- Participate in the selection of Contract Research Organization services as required for larger projects.