Manager, Clinical Operations

Manager of 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'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