Sr. Scientist, Nonclinical Development

Description

Mozart Therapeutics is an early clinical phase biopharmaceutical company located in Seattle, focused on developing novel immune engagers that specifically target a subset of T lymphocytes to delay the onset and ameliorate pathology of autoimmune diseases. We are developing first-in-class immune modulators that specifically target a novel regulatory T cell network. The company is seeking a highly motivated and experienced individual to join the Non-Clinical Development group. The ideal candidate will be an experienced scientist that will directly contribute to understanding the safety of candidate drugs in toxicology models and the translation of IND-enabling studies to the clinical development of Mozart’s therapeutic candidates.

This position requires knowledge and experience in non-GLP and GLP studies and regulatory guidelines to guide the design and execution of IND enabling studies, with knowledge and experience with studies to support late-stage clinical development. A scientist with a good understanding of T-cell biology and impact of therapeutics on lymphocyte function in non-clinical and clinical studies is desired. A working understanding of PK/PD approaches that inform pharmacology of candidate drugs is also desired.

Responsibilities

• Plan and execute safety studies required for development programs including experiments and strategies to enable the non-clinical IND-enabling path for selected therapeutic candidates.
• Expertise to contribute to study protocol design, monitoring studies during in-life phases and data analysis / report generation. Includes oversight of assay transfer, implementation and execution of assays, as needed, at non-clinical or clinical CROs.
• Contribute associated study materials reports, incorporating GxP processes, and adhering to regulatory guidelines.
• Perform data processing and analysis, including study interpretation; ability to troubleshoot and propose next steps to advance projects.
• Contribute to develop strategies to understand PK/PD relationships, as appropriate.
• Collaborate and contribute functional area expertise to multidisciplinary teams in the progression of development candidates.
• Contribute to generation of regulatory documents (e.g., sections on toxicology model justification, study summaries and pharmacology in tox species) to support initial IND and/or long-term development strategies.
• Adhere to non-clinical timelines and overall project plans to advance projects through Lead Candidate Selection and into clinical development.
• Potential to recommend and develop pharmacology and/or biomarker strategies to understand the pharmacodynamics and target engagement for candidates in IND-enabling safety studies (may include evaluation immunophenotyping (flow cytometry) and multi-plex cytokines/soluble protein panels).
• Mentor Scientists and Research Associates for scientific development across matrixed teams, as needed.
• Represent the company/program teams at scientific conferences and in internal meetings with senior management.

Requirements

• Experience in the design of the non-clinical strategies for protein biotherapeutics and contribution to study protocols, oversight and reporting.
• Interpretation of study data and reports and study summaries to advance a project through the research pipeline to IND submissions and understanding of drug development.
• Track record of working, managing and monitoring CROs that support IND-enabling safety studies, including experience with assay transfer, and validation of methods for the development of immune modulatory biologics.
• Understanding of NOAEL, MABEL, and PK/PD approaches to translate non-clinical study data to inform first in human clinical doses and clinical exposure.
• An understanding of T-cell biology and methods to understand pharmacology of candidates in toxicity models; previous experience in non-clinical development of candidates for autoimmune diseases is desired.
• 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.
• Experience in mentoring others working in a matrixed team environment.
• Experience working in a highly collaborative and dynamic research environment.
• Expert in use of scientific software and applications (including, for example, FlowJo, GraphPad Prism, JMP, Phoenix WinNonLin) and MS Office programs.
• B.S. with 16+ years of experience, an M.S. with 12+ years of experience, or a Ph.D. with a minimum of 5-8 years of relevant industry experience in immunology, pharmaceutics, cell biology, pathology or a related field with experience in the areas of immunotoxicology/toxicology, immunology and/or non-clinical/clinical pharmacology to support therapeutic candidates in a biotechnology setting.

Mozart Therapeutics has an innovative, fast paced, collaborative culture looking to hire individuals who are seeking to make a significant contribution to advancing and developing novel CD8 Treg 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.

The salary range is $112,970 min to $173,030 max. Fully qualified candidates will be paid in proximity to the salary mid-point.

We offer our employees competitive compensation including annual performance bonuses and stock option grants. The wage range shown is based on the job posting’s primary location. Actual compensation packages are based on a wide array of factors, including but not limited to skill set, experience, certifications, and location, in addition to internal equity and alignment with market data. Benefits include paid vacation, paid sick leave, paid holidays, and paid time off between Dec 25 and Jan 1, medical, dental and vision insurance, life insurance, 401(k) with company matching and stock options. All benefits are non-contractual and may be amended, terminated, or enhanced as Mozart Therapeutics deems necessary. We are an equal opportunity employer.