Manager, Clinical Operations

iota Biosciences, Inc.•Alameda, CA

11d•$145,000 - $200,000

About The Position

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.

Requirements

Bachelor’s degree in a scientific field
Minimum 8+ years of relevant clinical research experience in the medical device field, or an advanced degree with a minimum of 5 years of relevant experience in the medical device field
Proven success building and managing clinical operations teams
Comprehensive knowledge of clinical operations including Good Clinical Practices and all applicable US regulations
Experience with global clinical studies (e.g., EU or APAC regions)
At least 2 years monitoring experience
Experience with Class III medical device clinical studies
Effective verbal and written communication skills
Organized, self-motivated, ability to effectively manage multiple projects and priorities; high attention to detail
Must be a strong team player and effectively interface with other departments including translational medicine, regulatory, quality, product development

Nice To Haves

Clinical research certification (e.g., CCRP, CCRA, etc)
Experience with site and sponsor FDA BIMO inspections
Superior problem-solving skills.
Experience with urology clinical studies
Effective interpersonal/communication skills

Responsibilities

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
Provide input and support for post-clinical activities and market launch of products.
Establish / support cross-functional teams to ensure optimal alignment of Clinical, Regulatory, commercial goals, site operations, data monitoring and review, and safety surveillance and reporting expectations.
Ensure clinical research programs are conducted in accordance with company standard operating procedures (SOPs), Good Clinical Practice (GCP), and applicable regulations.