Senior Scientist/Principal Scientist, Non-Clinical Development
Mozart Therapeutics is an early-stage biopharmaceutical company located in Seattle, focused on developing novel immune modulators that specifically target a subset of T lymphocytes to delay the onset and ameliorate targeted autoimmune diseases. We are seeking a highly motivated and experienced individual who can work in a dynamic start-up environment to take on a functional area leadership role in Mozart’s Non-Clinical Development group. The successful candidate will be a skilled immunologist/cell biologist with experience that directly contributes to non-clinical pharmacology and IND-enabling studies supporting development of Mozart therapeutic candidates, including managing CROs and oversight of the execution of GLP studies. This position requires broad knowledge and hands-on experience of in vitro and in vivo studies to understand cross-reactivity across toxicology platforms and will support pilot and GLP studies to advance programs towards IND submissions. Strong understanding of T-cell biology and impact of therapeutics on T-cell function in non-clinical and early phase clinical studies and understanding of PK/PD approaches is required. A strong track record of previous scientific contributions resulting in program progression is also required. Previous experience in non-clinical development of candidates for autoimmune diseases is desired.
- Provide scientific execution for development programs including experiments and strategies to enable the non-clinical path for selected therapeutic candidates.
- Adhere to the project’s non-clinical timelines to advance projects from Lead Candidate Selection into clinical development.
- Design and perform critical path pilot (non-GLP) and GLP non-clinical studies to advance novel therapeutic molecules for the treatment of patients with autoimmune diseases.
- Develop biomarker strategies for IND-enabling safety studies and early clinical phases of development, including evaluation of cytokines/soluble proteins, immunophenotyping (flow cytometry), and bioanalysis and pharmacokinetics associated with non-clinical studies.
- Perform laboratory bench work, as needed, to support assay development, evaluate and select techniques, procedures, and criteria as it pertains to early pilot and non-clinical studies of selected therapeutic candidates.
- Perform data processing and analysis, integrate, interpret, and present data, make conclusions, and propose next steps to advance project.
- Contribute to regulatory documents and associated materials, incorporating GxP processes, reports, and guidelines.
- Collaborate and contribute to multidisciplinary teams in the progression of development candidates.
- Represent the company/program teams at scientific conferences and in internal meetings with senior management.
- Candidates at the Sr. Scientist level should have a PhD with minimum of 5 years or MS level with minimum of 12 years experience. Candidates for the Principal Scientist level should have a PhD with a minimum of 8 years or MS with a minimum of 15 years experience. Experience should be in the therapeutic areas of non-clinical pharmacology, non-clinical safety and/or immunotoxicology to support candidates in autoimmune diseases in a biotechnology setting. Graduate degree in immunology, cell biology, pathology or a related field with relevant preferred previous industry experience is preferred.
- Demonstrated track record in advancing a project or program through non-clinical development and supporting IND submissions.
- A broad understanding of the requirements of drug development and experience in the design of the experimental strategy for non-clinical animal models in the development of immune-modulating therapeutics is required.
- Understanding and experience with MABEL and NOAEL approaches to inform first in human clinical doses and clinical exposure.
- Excellent critical thinking and scientific acumen, with a demonstrated ability to analyze, interpret, and clearly communicate (orally and in writing) complex results and their impact to program and regulatory strategy.
- Track record of working with CROs for non-clinical studies and support of IND-enabling studies including experience with oversight of assay development, transfer, and validation of methods for the development of immune modulatory biologics.
- Prior project/leadership experience is preferred at the Sr. Scientist level and required at the Principal Scientist level
- Experience working in highly collaborative and dynamic research environment.
- Expert in use of scientific software and applications (including, for example, FlowJo, GraphPad Prism, JMP, SoftMaxPro) and MS Office programs
Mozart Therapeutics is an innovative, fast paced, collaborative culture looking to hire individuals who are seeking to make a significant contribution to advancing and developing novel immune modulators that target a subset of T lymphocytes to improve clinical outcomes in patients with autoimmune diseases. We are a well-funded privately held biopharmaceutical company founded in 2020. We offer our employees competitive compensation and benefits, including paid time off, health insurance, life insurance, 401(k) with company matching and stock options. Qualified candidates should forward their resumes to email@example.com. We are an equal opportunity employer.