Rénibus Therapeutics® Inc., is seeking to hire a Manager, Drug Development to assist with data analysis and strategic development initiatives.

This role reports directly to the Vice President of Drug Development and Medical Affairs. The candidate must be high-functioning, self-motivated, and able to work independently.

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    Responsibilities:

    • Clinical data analysis, including trend identification 
    • Investigate key preclinical and clinical findings from Renibus pipeline
    • Prepare summaries, reports, and presentations of key findings
    • Assist with publication planning 
    • Conduct competitive intelligence
    • Assist with key opinion leader (KOL) outreach
    • Assist with management of clinical programs

    Qualifications:

    • PhD, PharmD, or MD 
    • Excellent critical thinking and analytical skills 
    • Superior oral and written communication skills
    • Self-starter and able to work independently and with ambiguity
    • Successful at multi-tasking
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    Rénibus Therapeutics® Inc., is seeking to hire a highly motivated Clinical Research Associate / Senior Clinical Research Associate (CRA) as an integral member of the Clinical Operations team

    The CRA will perform clinical trial monitoring and site management activities, ensuring clinical studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and applicable regulatory requirements. The individual will also provide overall support to the clinical project team and assist with various study activities, as needed.

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      Responsibilities:

      • Oversee the conduct of clinical study sites, ensuring compliance with SOPs, ICH-GCP, and applicable regulatory requirements
      • Ensure successful execution of pre-study site qualification, study activation, monitoring visits, and close-out visits, including timely completion of well-written monitoring reports
      • Perform source documentation verification (SDV) of electronic case report forms (eCRFs), ensuring good documentation practices are being adhered to, including timely completion of data entry, proper reporting of protocol deviations, and implementation of corrective actions plans, as necessary
      • Ensure audit and inspection readiness of clinical study sites
      • Support study sites in meeting study goals, including enrollment
      • Maintain timely communication with study sites and Renibus clinical project team
      • Escalate any issues, as necessary, to the Renibus clinical project team 
      • Support Renibus clinical project team in clinical operations activities, as needed 
      • Complete all required training (general, SOPs, and study-specific) on-time

      Qualifications:

      • RN or BA/BS degree in biomedical-related field, life sciences or equivalent field or equivalent work experience
      • 3+ years of experience as a CRA in Pharma/Biotech industry or CRO
      • Adept at using electronic data capture (EDC) and electronic Trial Master File (eTMF) systems
      • Excellent oral and written communication skills 
      • High level of organization, multi-tasking, judgement, and efficiency
      • Profound knowledge of ICH-GCP and other relevant regulatory requirements pertaining to clinical trial conduct
      • Willing/able to travel to investigational sites 40% of the time; note some visits may be conducted remotely
      • Must maintain a valid driver’s license and the ability to drive to monitoring sites
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      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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      Applicant Information

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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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