Responsible for the clinical and laboratory operations for pre-clinical to phase III clinical trials (50+ clinical trials, 200+ investigative sites) conducted by the ITN. Oversee and direct operations staff on the development and implementation of assigned trials. Ensure clinical trials are conducted in compliance within ITN operational policies and regulatory standards related to safety, compliance, ethics, and oversight of human research. Administer and serve on external committees. Develop, implement, and manage systems which support clinical operations. Lead departmental strategic initiatives. Assess and set departmental priorities. Provide training and mentorship to staff. Establish strong relationships with sponsors, partners, and key stakeholders to maximize project success, impact and sustainability.

Responsible for directly managing multiple clinical trials, supervising operations staff who manage or support other assigned clinical trials, and provide input and support for strategic initiatives, planning and managing the activities which include feasibility reporting, protocol and CRF development, budgeting, and site management.

Oversee and provide operational expertise for all phases of IND clinical studies. Provide input into design of clinical protocols. Development of project timelines and implementation of processes for study conduct according to Good Clinical Practices. Negotiate and prepare contracts, budget proposals CDAs.