Manager, Clinical Operations
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About this role
About Us
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.
The Role
We’re seeking a Manager of Clinical Operations to lead the oversight, planning, coordination, and execution of clinical projects for our Class III active implantable device program. This role requires direct, hands-on experience running clinical trials for Class III active implantable medical devices.
In this role, you’ll manage clinical operations staff and vendors, and help bring a first-of-its-kind bioelectronic therapy to an underserved patient population
What You’ll Do
Manage a high performing clinical operations team by providing direction, subject matter expertise, training and mentorship.
Design, develop, and evaluate clinical execution plans (protocol, CRFs, consent forms, source documents, budgets, timelines, gap analyses).
Own end-to-end clinical trial execution: study start-up, site activation, site management, vendor oversight, study reports, and site/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.
What we’re looking for
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
At least 3 years monitoring experience
Experience specifically with Class III medical device clinical studies (required)
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)
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
Preferred Qualifications
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
What makes this role unique:
Innovation – first of its kind device that will require a unique clinical study design.
Build & Lead – you’ll bring clinical operations expertise to the department and have the opportunity to influence department strategy and implementation
Impact – clinical studies are a critical part of product development. Your work here will directly influence time to market and providing a new therapy to an underserved patient population.
iota offers a very competitive benefits package that includes the following:
Health & Wellness
Comprehensive health coverage for you and your family, covered at 100%
Access to quality dental and vision coverage
Onsite Gym in Alameda
Work-Life Balance
Generous vacation pay
Paid parental leave
Options for flexible work schedules
Competitive Compensation
Annual Bonus Plan
Long Term Incentive Plan (LTIP)
401(k) plan with employer match
Company
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