Director / Associate Director – Toxicology

Monte Rosa Therapeutics, Inc•Boston, MA

About The Position

Monte Rosa Therapeutics is searching for a Toxicology Lead to direct nonclinical safety and toxicology work for programs to enable drug candidates from discovery through development. This position will lead and develop nonclinical toxicology strategies to support Monte Rosa’s diverse drug candidates during all phases of development. The Toxicology Lead will contribute to the R&D strategy and implement the strategy and will report to the Senior Director of Nonclinical Development. This is an individual contributor role by designing, conducting or overseeing studies, analyze/interpret, and report in vitro, ex vivo, and in vivo non-GLP (or GLP studies conducted at CROs) nonclinical pharmacology, PK/PD, and/or toxicology studies, in collaboration with study monitors and other scientists. Ensure appropriate quality of documentation and record keeping. The Lead scientist will support global regulatory activities related to nonclinical sections of filings including INDs, IBs, and annual reports. The discovery toxicologist interacts directly with multidisciplinary teams including biology, medicinal chemistry, DMPK, clinical science, and outside CRO’s in research and/or development projects to move discovery candidates into development. Introduction and growth into regulatory toxicology will be an extension of this position. The ideal candidate will be able to help evolve Monte Rosa’s hit identification and hit-to-lead endeavors through embracing novel assay technologies, enhancing overall process and actively drive internal and external partnerships.

Requirements

PhD degree or DVM & 5 yrs of scientific experience OR Master’s degree & 10 years of scientific experience in preclinical toxicology and drug development in the pharmaceutical/biotechnology sector; DABT preferred
Familiarity with GLP regulations and ICH/FDA guidelines for the conduct of toxicology studies to support regulatory filings
Experience working with Contract Research Organizations
Ability to develop and deliver clear and concise presentations for both internal and external meetings
Outstanding written and verbal communication skills

Responsibilities

Develop Toxicology studies for Molecular Glue Degraders by bridging Monte Rosa’s platform to aid in the understanding/minimizing of potential issues.
Work cross functionally and culturally with departments on in vitro and in vivo models, weaving in toxicological datapoints to help mitigate findings.
Participate in the design of early in vitro toxicity screening and/or secondary/safety pharmacology studies for small molecules in various stages of preclinical research and development. Implement and manage studies with CRO and/or academic collaborators.
Execute studies designed to address mechanistic issues and/or unpredicted adverse findings in preclinical and/or clinical trials and provide results on a timely basis to support the ongoing project teams and leadership team.
Select CROs and represent Monte Rosa as the Study Monitor for various in vitro and in vivo toxicology studies.
Responsible for protocol design and reviewing protocol amendments.
Review all experimental data and ensure timely delivery of toxicology reports that may be used for regulatory submissions and assist in the preparation of safety pharmacology and toxicology sections for Investigational New Drugs (INDs), annual reports, Investor Brochures (IBs) and New Drug Applications (NDAs).

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