Careers

Together,
we can accomplish more.

If you’re patient focused, passionate about what you do, and have an entrepenuerial spirit, you might be interested in learning more about working with us.

Explore Renibus’ career opportunities:

Join Our Team

Document Specialist

Renibus is a clinical-stage biotech company focused on the prevention and treatment of cardo-renal diseases. Our team is conducting a Phase 3 trial with RBT-1, a novel drug which is being studied in patients undergoing cardiac surgery. Our phase 2 clinical data suggests that the treatment can improve outcomes. The U.S. FDA has granted RBT-1 a fast track and Breakthrough Therapy designation, which speaks to the promise of the drug. We are seeking a Document Specialist to be a part of our dynamic, passionate, and driven team that values collaboration, innovation, and diversity. This individual, through collaboration with various team members, is accountable for the creation, maintenance and archival of the Trial Master Files/ eTrial Master Files to ensure audit readiness. A minimum of 3 years’ experience in the use of an eTMF system and knowledge of the TMF Reference Model, supported by DIA is preferred.

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Responsibilities:

  • Conducts quality control and/or completeness checks, in accordance with Renibus’ SOPs and operational best practices relating to document management, to ensure accuracy of files within TMFs; Support the review of document quality data and audit outputs
  • Assists in creation, maintenance and archival of Trial Master Files/ eTrial Master Files in accordance with Renibus Standard Operating Procedure (SOP), GCP, EMA and FDA regulations and the TMF Reference Model, supported by DIA
  • Assists Inspection Readiness Team and Clinical Project/Trial Manager in tracking eTMF related activities/milestones/metrics
  • Runs eTMF metrics for project teams; follows up with vendor/ project teams if required
  • Assists/supports project teams with preparation for audits/inspections (internal and external)
  • Develops TMF knowledge with progression towards subject matter expert for eTMF systems
  • Under supervision, may assist with tasks typically associated with GCP Documentation Specialist study such as clinical document/ report review, ICF template generation and/or review, review IP release packet prior to initiation, etc.
  • Serve as TMF contact and Subject Matter Expert for the clinical study team and supporting cross-functional departments including TMF process education to ensure high quality documentation
  • Assists in the collaboration with the internal cross-functional project team and vendors to resolve discrepancies and ensure timely completion of internal tasks, as they relate to TMF deliverables.
  • Maintains a working knowledge and ensures compliance with applicable ICH-GCP Guidelines, local regulatory requirements, Renibus SOP and study-specific procedures.
  • Classify and index electronic TMF (eTMF) and clinical development documentation with accurate attributes and metadata according to company standards, Good Clinical Documentation Practices, and project-level Trial Master File Plan and Index
  • Monitor TMF health/report metrics throughout the study according to TMF plan and deliver KPI reports and dashboard to the study team
  • Execute planned and ad hoc Quality Control (QC) procedures, identify and record quality issues; provide solutions and resolve issues; identify documentation trends and perform corrective training to team members as needed based on TMF QC findings
  • Support audit/inspection activities, internal Compliance/Quality procedures and process improvement
  • Executes change management to ensure consistent application and best practices of revised standards, processes, and systems functionality across study teams
  •  Providing best practice guidance and support to ongoing and ad-hoc TMF projects and initiatives.
  • Maintain up to date training records per Renibus SOPs, processes and procedures

Qualifications:

  • Minimum of 3 years’ experience in use of eTMF system (e.g., clinical site, CRO, Sponsor or clinical trial vendor).
  • Knowledge of the TMF Reference Model, supported by DIA
  • Comfortable with technology and ability to learn new systems quickly.
  • Relevant experience in clinical research (clinical operations and/ or QA preferred) or related field.
  • Exposure to current regulatory requirements and guidelines governing clinical research and GCP
  • Requires attention to detail in composing and proofing materials, establishing priorities, scheduling, and meeting deadlines.
  • Must be able to professionally interact and communicate with visitors, vendors, and individuals at all levels of the organization.
  • Must be able to work in a fast-paced environment with demonstrated ability to appropriately prioritize competing tasks and demands.
  • Ability to work proactively and successfully within a cross-functional team.
Sr. Clinical Trial Manager

Renibus is a clinical-stage biotech company focused on the prevention and treatment of cardo-renal diseases. Our team is conducting a Phase 3 trial with RBT-1, a novel drug which is being studied in patients undergoing cardiac surgery. Our phase 2 clinical data suggests that the treatment can improve outcomes. The U.S. FDA has granted RBT-1 a fast track and Breakthrough Therapy designation, which speaks to the promise of the drug. We are seeking a Sr. Clinical Trial Manager to be a part of our dynamic, passionate, and driven team that values collaboration, innovation, and diversity. This individual will assist with our phase 3 trial, providing day-to-day, site facing, operations of the project, and ensuring deliverables are met in terms of quality, compliance, and timing. Comprehensive knowledge of clinical trial regulations, guidelines, and best practices, including ICH-GCP is required. A Bachelor’s degree in a health-related field and a minimum of 5 years as a project/clinical trial manager is preferred.

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Responsibilities:

  • Manage and provide day-to-day, site facing, operations of the project, according to ICH/GCP and all other applicable laws, rules, and regulations
  • Drives site start-up activities
  • Serve as primary contact for site facing operational project-specific issues and study deliverables to ensure optimal Sponsor-Site relationships
  • Coordinates the development and distribution of critical study documents, including ICFs, operational documents, study reference documents, study newsletters, site materials, and other study related documents.
  • Supports the development of clinical study protocols, clinical study reports and other documents as needed
  • Maintain in depth knowledge of protocol, therapeutic area, and indication
  • Develops site budget template and negotiates the budget
  • Develops Clinical Trial Agreement and negotiates to execution
  • Develops and maintains KPIs and timelines, for site activation and enrollment to ensure cross-functional alignment of expectations, priorities, and deliverables
  • Plan and prepare for investigator meetings
  • Oversee forecasting of clinical supplies and non-clinical supplies for a study
  • Review and provide input for data management edit check specifications, and data analysis plan
  • Manage risk assessment, and execution of mitigation strategies for both the clinical study and investigative sites
  • Manage site quality
  • May function in the role of Project Manager for assigned projects
  • Mentor junior staff as needed

Qualifications:

  • Bachelor’s degree in a health-related field; Advanced degree in a health-related field preferred
  • Experience in Phases 1-4; Phases 2-3 preferred
  • 5+ years as a project/clinical trial manager
  • Strong leadership skills
  • Comprehensive knowledge of clinical trial regulations, guidelines, and best practices, including ICH-GCP is required

About Renibus Therapeutics

Renibus is a clinical stage biopharmaceutical company dedicated to treating, improving, and extending patients’ lives by developing products to prevent disease progression, improve outcomes and protect against organ damage associated with cardio, renal and metabolic diseases. Renibus’ first-in-a-new class lead program is RBT-1 (stannic protoporfin / iron sucrose), a single dose IV drug that is given over 1-2 hours, 24-48 hours prior to patients undergoing elective cardiac and/or valve surgery. It is in a Phase 3 pivotal trial to reduce the risk of post operative complications and improve outcomes following cardiothoracic surgery. The drug has received FDA Breakthrough and Fast Track Designations.

Veverimer (Alezuris™) is an oral, non-absorbed hydrochloric acid binder that was acquired from Tricida. We are currently evaluating veverimer in preclinical models and analyzing historical data to further our understanding of its clinical profile with a goal of identifying an indication for evaluation in a Phase 2 trial.

RBT-3 (iron sucrose), one component of RBT-1, is a novel, low molecular weight iron nanoparticle that has the potential to rapidly restore iron levels and improve blood product utilization in cardiac surgery and/or ER patients.  RBT-3 has also demonstrated the potential to mitigate cisplatin induced nephrotoxicity in preclinical models.  We are currently exploring opportunities to further the clinical development of RBT-3 in these potential indications.

RBT-9 (stannic protoporfin), another component of RBT-1, is a potent anti-inflammatory and antioxidant drug. It has completed Phase 1 (as part of the RBT-1 program) and has been investigated in a 42-patient Phase 2, randomized, placebo-controlled trial in high-risk patients with COVID-19. The data from this trial indicated that RBT-9 has the potential to significantly improve clinical outcomes. Additional work is underway to help inform the future clinical development strategy.

RBT-2 (tetrahydrocurcumin) is an oral antioxidant and antifibrotic drug that is in IND enabling studies targeting delaying CKD progression.

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