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:

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Senior Safety Manager

Position Summary:

Lead and manage the Clinical Safety Pharmacovigilance (CSPV) function by providing pharmacovigilance expertise regarding the creation, implementation and maintenance of the pharmacovigilance processes, compliance with safety management policies procedures and plans, and ensuring  maintenance of the pharmacovigilance system master file.

Key skillsets include GCP knowledge regarding safety reporting and oversight, strong interpersonal skills including written and verbal communication skills, strong organizational skills with attention to detail.

Department: Clinical Operations

Reports To: Vice President of Clinical Operations

Job Responsibilities

  • Overall accountability for management of CSPV
  • Close interaction with other departments; Clinical Operations, Data Management, Research, Regulatory, Quality Assurance, Manufacturing/CMC) and any partners/vendors, as applicable
  • Oversight of Pharmacovigilance (PV) standards within the CSPV functional area including the management of Standard Operating Procedures, policy documents and processes relevant to PV
  • Develop, implementation and ongoing management of study-specific Safety Management Plan (SMP) and Case Report Forms
  • Issuing and resolving safety queries in the study database
  • Manage accurate and timely safety related regulatory reporting (AEs, SAEs, SUSARs) per study and regulatory requirements including collaboration with regulatory affairs and clinical operations, or overseeing activities of third-party managing safety reporting
  • Coordinate ongoing medical reviews of safety related events (per study SMP)
  • Oversight of safety management across clinical studies
  • Review of adverse event coding in the EDC for accuracy, in collaboration with Data Management
  • Mentor/Train other staff, contractors, and vendors regarding the pharmacovigilance processes
  • Maintenance of safety documents to include in the Pharmacovigilance System Master File Management
  • Overview of Clinical and Safety Pharmacovigilance vendors, or contractors, if applicable
  • Global and Local compliance Management
  • Establishes and maintains key Performance Indicators (KPI) for the PV system and continuously monitors the global PV system compliance
  • Review applicable study reports and statistical outputs as needed
  • Serves as a contact for any PV matters internally and externally as requested
  • Other duties as assigned

Skills. Qualifications and Requirements

  • Bachelor’s Degree required, preferably in nursing or life sciences
  • Minimum of 7 years’ experience in PV in the biotechnology/pharmaceutical industry
  • Knowledge of domestic and international laws, regulations and policies governing pharmacovigilance
  • Excellent command of English with strong written and oral skills, including experience in medical and regulatory terminology (Medical Dictionary for Regulatory Activities -MedDRA)
  • In-depth knowledge and skills in the use of database applications, MS Office, and other relevant software
  • Highly self-motivated individual able to work with minimal supervision
Clinical Scientist

Renibus Therapeutics is seeking to hire a Clinical Scientist to assist with data analysis and strategic development initiatives. This role reports directly to the Vice President of Drug Development. The candidate must be high-functioning, self-motivated, and able to work independently.

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 development

Qualifications:

  • PhD in a field of biomedical sciences
  • 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

About Renibus Therapeutics, Inc.

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.

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, which is in a Phase 3 pivotal trial to show a reduction in post-operative complications and improve outcomes following cardiac surgery. The drug has received FDA Breakthrough and Fast Track Designations.

Veverimer is an oral, non-absorbed hydrochloric acid binder that was acquired from Tricida. We are targeting several indications where Veverimer’s mechanism of action as a hydrochloric acid binder within the gastrointestinal tract may provide benefit in treating orphan diseases with an unmet medical need.

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