Manager, Clinical Operations

iota Biosciences, a wholly owned subsidiary of Astellas Pharma US, is advancing a new class of bioelectronic medicines through the development of fully implantable active Class III medical devices. Our proprietary technologies open therapeutic and diagnostic possibilities not previously accessible to clinicians.

Together with Astellas, we are committed to patient-centric design, scientific and engineering excellence, and cross-functional teamwork. These principles guide us in bringing transformative, first-of-its-kind technologies into the clinic and closer to patients.

We are seeking a Manager of our Clinical Operations team, to provide leadership in the oversight, management, planning, coordination, and execution of clinical projects. This is a highly hands-on role for someone who wants to impact company development through effective and efficient management of clinical operations staff and activities.

This role is ideal for someone who has experience in global Class III active implantable medical device studies, who can manage teams and vendors efficiently and effectively, and who wants to help bring a unique product to market for an underserved patient population.

Manage a high performing clinical operations team by providing direction, subject matter expertise, training and mentorship.

Responsible for managing the design, development, modification, and evaluation of clinical execution plans (e.g., protocol, case report forms, consent forms, source document worksheets, budget, timelines, gap analysis, etc.)

Accountable for the comprehensive clinical trial activities including but not limited to study start-up, site activation, site management, vendor oversight, study reports, site and study close-out.

Provide technical direction to clinical research organizations (CROs) and oversee vendor selection/management as needed to execute clinical studies.

Work closely with hospitals and investigators participating in clinical studies and maintain close working relationships with KOLs, other investigating physicians and site coordinators