Rénibus Therapeutics® Inc., a clinical stage biotechnology company focused on changing the cardiorenal treatment paradigm, is seeking a highly motivated Clinical Operations leader to join our growing clinical development program.

The Director, Clinical Operations is responsible for leading the Clinical Operations team and overseeing all operational aspects of clinical studies. This individual will assess operational feasibility and prepare study execution plans; coordinate resources, timelines, and budgets; manage data collection and monitoring activities; and ensure compliance with SOPs/GCP guidelines. The Director, Clinical Operations must be a direct contributor to the responsibilities of the Clinical Operations team and able to work efficiently in a fast-paced environment and within a small team.

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    Responsibilities:

    • Lead and manage in-house clinical operations activities for multiple clinical programs, including project management oversight
    • Contribute to the writing and review of clinical documents, including but not limited to: protocols, informed consents, investigator brochures, monitoring plans, and clinical study reports
    • Oversee data management and eTMF management
    • Manage CRAs and monitoring activities
    • Oversee safety management team
    • Review and negotiate CTAs and site budgets
    • Review and approve study site and vendor invoices
    • Identify and/or anticipate operational risks and mitigation plans across trials within the development program and communicate issues to senior management
    • Track major study milestones and monitor overall operational performance metrics through the life of each study
    • Develop patient recruitment strategies and ensure operational feasibility and timely implementation of study goals
    • Create, review, and modify company SOPs as necessary
    • Provide direction, training and follow-up to ensure compliance with organization goals, as well as department and corporate policies and procedures
    • Ensure that clinical trials are conducted in compliance with ICH, GCP and applicable regulatory requirements and that reported trial data are accurate, complete and verifiable from source documentation

    Qualifications:

    • Minimum 10 years of experience in clinical research and operations within the biotech/pharmaceutical industry
    • Demonstrated ability to lead and develop Clinical Operations teams
    • Extensive knowledge of clinical development processes, regulatory requirements, and ICH/GCP guidelines
    • Skilled at effectively leading, coaching, and managing teams to achieve deliverables on time and on budget
    • Exceptional organizational skills and ability to work in a fast-paced environment with minimal direction
    • Must be self-motivated and “hands-on”
    • Must possess excellent critical thinking and communication skills
    • Must be flexible in adapting to changing program needs
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    About Rénibus Therapeutics® Inc.

    Renibus Therapeutics is a clinical-stage biotech company dedicated to transforming the cardiorenal disease treatment paradigm by focusing on the prevention and treatment of kidney disease. The company’s portfolio includes RBT-1 for prevention of acute kidney injury, RBT-2 for treatment of chronic kidney disease, and RBT-3 for treatment of iron deficiency anemia and platinum-based kidney toxicity.

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