Associate Director / Senior Scientist - Toxicology

Monte Rosa Therapeutics Boston , MA

Posted 3 weeks ago

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 Rosas 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 CROs 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 Rosas hit identification and hit-to-lead endeavors through embracing novel assay technologies, enhancing overall process and actively drive internal and external partnerships.

Principal Duties and Responsibilities

1. Develop Toxicology studies for Molecular Glue Degraders by bridging Monte Rosas platform to aid in the understanding/minimizing of potential issue

2. Work cross functionally and culturally with departments on in vitro and in vivo models, weaving in toxicological datapoints to help mitigate findings

3. 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.

4. 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.

5. Select CROs and represent Monte Rosa as the Study Monitor for various in vitro and in vivo toxicology studies.

6. Responsible for protocol design and reviewing protocol amendments.

7. 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).

Requirements

  • PhD degree or DVM & 5 yrs of scientific experience OR Masters 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
icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Scientist Director Metabolomics Facility

Dana-Farber Cancer Institute

Posted 3 weeks ago

VIEW JOBS 1/4/2022 12:00:00 AM 2022-04-04T00:00 Overview Dana-Farber Cancer Institute is seeking an experienced PhD-level Metabolism Scientist to lead the Institute's new small molecule metabolomics core facility, to develop and apply state of the art approaches and to investigate cellular and organismal metabolism. Located in Boston and the surrounding communities, Dana-Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow's physician/researchers; we reach out to underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals. Responsibilities * Lead the design and execution of experiments to deliver a diverse set of metabolomics data, including targeted and non-targeted steady-state metabolomics as well as stable isotopic labeling data and flux analysis. * Provide scientific and technical leadership to promote metabolomics at Dana-Farber and among the Institute's academic and industry collaborators. * Develop the Institute's metabolomics platform, working in collaboration with the Core's industrial metabolomics partners to apply in-licensed metabolomics tools, and over time establish novel metabolic capabilities to further enhance discovery research. * Use both commercial and proprietary informatics/software tools for analysis of complex data from metabolomics (targeted and untargeted) and flux experiments to evaluate cellular metabolism; interpret results in the context of current literature and established metabolic understanding. * Implement best practices for operation and maintenance of core instrumentation. * Develop operating budgets using established accounting standards to insure the sustainable financial operation of the facility. * Manage the Core's scientific and technical staff and create a positive, supportive work environment within the Core. * Interact proactively with Dana-Farber researchers and collaborators. Qualifications * The candidate should hold a PhD in any area of the chemical, biological, or biochemical engineering sciences plus at least two years of post-doctoral training. Industry research experience (bio/pharma R&D, metabolic engineering, synthetic biology) is a plus. * At least 5 years of experience with LCMS-based metabolomics data acquisition, instrument operation, and instrument maintenance. * Excellent track record of scientific research showing evidence of both analytical excellence and ability to address biology questions with depth, rigor, and creativity, as in peer-reviewed publications, scientific presentations and patent filings. * Informatics skills are a significant plus, including familiarity with Matlab, scripting languages (python, R, shiny), and more generally, aptitude operating within an informatically-driven research environment. * LCMS-based lipid profiling expertise is an asset for this role. * The ideal candidate will be comfortable working at the interface of chemistry and biology, dealing with quantitative physical measurements, and concepts of metabolic flux analysis and stable isotope labeling studies. Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law. Dana-Farber Cancer Institute Boston MA

Associate Director / Senior Scientist - Toxicology

Monte Rosa Therapeutics