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 therapy for the treatment of lupus nephritis (LN). And we are actively hunting for other innovative drugs 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 for an important role that supports the design and oversight of Pharmacology and Toxicology programs for assigned biologic therapeutic candidates in development. Reporting to the Director of Research and Development (R&D), the successful candidate will be primarily responsible for the nonclinical pharmacology and toxicology studies conducted on behalf of Aurinia using Contract Research Organizations (CROs) or other external collaborators. The successful candidate will also represent preclinical development on project teams and/or sub-teams to support the development of biologics candidates in development. The opportunity is also open to an enthusiastic scientist who is keen to develop as a preclinical development scientist in an exciting biotechnology company.

Primary Responsibilities

• Serve as study monitor for the design, conduct and reporting of nonclinical Pharmacology and Toxicology studies performed at Contract Research Organizations (CROs) to ensure a quality final product.
• Write and edit nonclinical study protocols.
• Scientific and technical reviewer for nonclinical studies performed with external collaborators or CROs.
• Review and finalize study reports (both non-GLP and GLP studies).
• Build and develop partnerships with CROs.
• Responsible for Preclinical development SOPs and guidelines.
• Act as R&D representative on project teams and/or sub teams for the development of novel therapeutic drugs and targets.
• Write and review nonclinical safety documentation for regulatory purposes (IBs, IMPDs, INDs & BLAs).
• Communicate with regulatory agencies to resolve nonclinical issues.
• Present, discuss and review issues within R&D and other stakeholders.
• Work cross-functionally across the organization, including Regulatory, CMC, Clinical, Quality Assurance, and other groups.
• Present at and attend at scientific conferences.

• Ph.D. in Biomedical Sciences (e.g., Immunology, Toxicology or Pharmacology)
• Biological drug development experience, with minimum 2 years working in industrial pharmacology/toxicology
• Experience in coordination, organization, analysis, and documentation of nonclinical studies
• Ability to synthesize, organize, and analyze diverse, multidisciplinary data sets
• Excellent scientific writing and editing as well as written/oral communication skills
• Ability to work independently and collaborate with a multi-disciplinary group in a goal- and team- oriented setting
• Availability to travel to CROs for study monitoring activities
• Proficiency with MS Office and common laboratory software (GraphPad Prism, etc.).
• Working knowledge of regulatory guidelines relevant to preclinical development
• Understanding of FDA and OECD Good Laboratory Practice (GLP).

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