Director of Clinical Operations
 Okami Medical

Position Overview

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Okami Medical has developed a multi-platform peripheral vascular occlusion system supported by multiple patents, FDA clearances, and limited market commercial release. Okami Medical raised $32.5M in 2024 to drive U.S. commercialization supported by multiple clinical studies. Okami Medical is hiring its Director of Clinical Operations.

 

• Technology Video: Click here

• News Article: Okami Medical Appoints New CEO

• FDA: Okami Medical Announces 510(k) Clearances

 

We have partnered with Rhonda Robb, President & CEO, along with Terry Hardin, Vice President of R&D and Clinical, to hire our Director of Clinical Operations. This position will be responsible for setting up multiple registries to support post-market clinical studies and commercialization. The Director of Clinical Operations will work cross-functionally with the commercialization team to select sites for the registries, as well as interface directly with health system partners to develop and implement registry-related protocols. This position will also manage external consultants for field-related tasks and build out an internal team beginning in 2026.

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Responsibilities 

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• Develop and lead a clinical evidence strategy that aligns with company objectives and supports product adoption.

• Manage all aspects of clinical studies, including design, protocol development, budgeting, site selection, contracting, IRB submissions, investigator relationships, data collection, and monitoring.

• Develop and maintain study management plans to ensure timely execution and delivery of high-quality outcomes.

• Oversee site start-up activities, including contracting, budgeting, and training/site initiation preparation.

• Oversee site and vendor management, such as electronic data capture platforms and Contract Research Organizations (CROs), ensuring adherence to protocols and regulatory requirements.

• Develop and implement a systematic approach to evidence dissemination, including submissions to peer-reviewed journals and participation in key scientific meetings to elevate product awareness.

• Build and maintain relationships with clinical investigators to support studies, publications, and future research opportunities.

• Act as the primary contact for investigator-initiated studies, managing budget and contract negotiations.

• Collaborate with cross-functional teams (sales, marketing, regulatory) to ensure clinical evidence strategies align with business objectives.

• Lead the company’s Case Review program to ensure a steady flow of new cases for the commercial team.

• Manage the company’s internal case reporting program to monitor product performance and generate actionable insights.

• Foster continuous process improvements within clinical operations to enhance the efficiency and quality of clinical study execution.

• Ensure site and study compliance with protocols, Good Clinical Practice (GCP), SOPs, and regulatory requirements.

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Qualifications & Competencies 

• BS required. Advanced degree preferred (MS, or equivalent)

• Minimum of 8+ years of relevant clinical study experience in the medical device industry

• Strong understanding of clinical trial design and execution.

• Proven ability to work cross-functionally and communicate effectively with key stakeholders.

• Strong organization and project management skills.

• Proven ability to develop and execute post-market data strategies that align with growth objectives.

• Extensive experience managing multi-institution clinical studies and registries, from protocol development to execution and completion.

• Expertise in investigator-initiated studies, including budget and contract negotiations.

• Strong ability to manage site recruitment, training, contract negotiations, and IRB submissions.

• Proficiency in collaborating with CROs and other external partners to ensure high-quality data collection and site compliance.

• Demonstrated success in developing and executing clinical publication strategies to drive product adoption and elevate market awareness.

• Exceptional organizational and communication skills to lead cross-functional teams and manage multiple priorities effectively.

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Company Overview 

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Okami Medical, Inc. is a privately held medical device company with a mission to address the evolving needs of patients and physicians through the development of innovative, versatile, and intuitive devices for the occlusion of peripheral vessels. Okami designed the LOBO® Vascular Occlusion System to allow physicians to access and rapidly occlude a wide range of vascular targets. The company was created in 2017 by Inceptus Medical, a medical device incubator. Okami is backed by members of the board of directors, Vensana Capital, U.S. Venture Partners (USVP), and other medical device industry veterans.