Our Mission

Aurinia exists to make a difference. From the earliest days of the company, we’ve seen the potential in applying a creative, thoughtful and responsible approach to developing and commercializing therapies with a goal of changing the course for patients in disease areas that have been historically challenging to address. We Care, for our patients and our employees.

We are currently developing an investigational drug as a treatment of lupus nephritis (LN) and preparing for its potential commercialization. We are also looking to leverage our internal capabilities to advance additional innovative therapies which have the potential to change the lives of people with rare autoimmune and inflammatory diseases.

Aurinia is searching for an enthusiastic and creative scientist with leadership capabilities for an important role that can apply Pre-Clinical and Clinical Pharmacology knowledge, including pharmacokinetic/ pharmacodynamic analyses and principles of model-based drug development in programs for all stages of drug development. ranging from pre-clinical development through post-marketing support. This role will be instrumental in leading pharmacology activities for preclinical drug discovery projects.

Primary Responsibilities

• Contribute to overall compound development via application of quantitative methods to integrate knowledge of PK, PD, patient characteristics, disease states, and drug-drug interactions to optimize dose selection, dosage regimens and study designs throughout preclinical drug development.
• Lead pharmacology activities for preclinical drug discovery projects and contribute to overall program strategy, including ADME and DMPK.
• Collaborate on modeling and simulation activities in drug development programs. Perform and/or liaise for modeling and simulation analysis of preclinical-clinical data, translational PK/PD data, first-in-human (FIH) and if applicable beyond FIH (dose/exposure-response analyses to guide dose regimen from pre-proof of concept (POC) and POC studies).
• Execution of scientifically robust and efficient clinical pharmacology strategies for NME and/or development candidates.
• Applies the understanding of both the impact of intra- and inter-subject variability in physiology and/or pathology, concomitant medication use, and biopharmaceutics, on pharmacokinetics (PK) and PK/pharmacodynamics (PD), and the requirements for the clinical pharmacology regulatory submission packages and submission processes.
• Help design Phase I clinical pharmacology studies.
• Perform literature searches and summarize the findings.
• Manage operational elements of pre-clinical and clinical pharmacology studies.
• Contribute in monographs, INDs and other documents as applicable to support clinical studies and regulatory filings (e.g. NDA/BLA).
• Help to build out, lead, supervise and mentor members of the Pharmacology team.
• In collaboration with senior leadership, make key contributions to the overall Aurinia scientific strategy to create precision medicines for kidney disease.
• Contribute to the development and maintenance of a positive team-focused company culture.

• ​​​​PhD or equivalent degree in Pharmaceutical Sciences, Pharmacology, or other relevant Biological Sciences with 5 years of relevant experience (beyond postdoctoral studies).
• Experience with biologics preferred.
• Experience building a team is an asset.
• Ability to design and execute PK, PK/PD modeling efforts and address the unique challenges pertinent to the project including the use of NONMEN, SAS and R.
• Applicative knowledge of regulatory (e.g., FDA, EMA, ICH, etc.) guidelines in the design of clinical development plans and studies.
• Current knowledge of clinical and drug development information and methods in modeling and simulation; engaged with the scientific community (e.g., publishing, presenting at meetings, participating in special interest groups within professional societies, etc.) and constantly looking for innovative ways to solve problems. Able to internalize key learnings back to Aurinia.
• Ability to efficiently manage operational elements of Clinical Pharmacology studies.
• Experience managing deliverables in accordance with timelines and overall project goals.
• Interpersonal skills condusive to building relationships with internal and external stakeholders
• Ability to work independently and collaborate with a multi-disciplinary group
• Strong attention to detail and writing skills that can be leveraged to assist senior members to prepare documents for regulatory interactions (e.g. pre-IND, EoP1, EoP2, NDA/BLA filing etc.).
• Enthusiastic individual contributor with superior analytical and organizational skills.
• Ability to lead and inspire other functional contributors.

All candidate information will be kept confidential according to EEO guidelines.