Location: Cambridge MA
Cambridge, MA-based H3 Biomedicine (https://www.h3Biomedicine.com/) is a leading company in cancer genomics driven drug discovery, delivering on the promise of precision medicine. The company was launched in 2011 with an unprecedented $200 million in initial funding from Eisai, plus a continued ongoing commitment to fund H3’s robust discovery pipeline and clinical programs. Now with three clinical stage anti-cancer molecules in active development, H3 is able to uniquely leverage distinct insights from cancer genomics and real-life patient data to advance its projects to clinical proof of concept and beyond. H3 embraces a novel business model in which it collaborates with Eisai, a leading global pharmaceutical company, to create a prolific drug discovery engine and partnership platform.
H3 Biomedicne is searching for a Scientist to be the safety/toxicology lead on research discovery project teams, and designs and implements the toxicology strategy to evaluate early leads and for lead optimization of potential clinical candidates. Oversees safety assessment of the target, conducts in vitro safety pharmacology and toxicity screening studies, and/or develops new screens in partnership with CROs. Conducts mechanistic, hypothesis-driven investigations of lead compound, with the goal of delivering a clinical candidate or de-risking existing clinical candidates. Provides data analysis and interpretation of toxicology studies for project teams, works as part of a multidisciplinary team to support the conduct of pre-clinical studies, involved in strategic planning and design of toxicology programs on teams. The discovery toxicologist interacts directly in research and/or development projects with multidisciplinary teams including biology, medicinal chemistry, DMPK, clinical science, and outside CRO’s to bring discovery candidates into development. Performs quality control checks on nonclinical safety pharmacology and toxicology documents for regulatory submission.
Principal Duties and Responsibilities
- Represents Toxicology on multidisciplinary team to support the conduct of pre-clinical studies for H3 projects from early discovery phase through lead optimization and candidate selection.
- Perform early safety assessment on novel targets and assist in developing risk mitigation strategy
- Design early in vitro toxicity screening and/or secondary/safety pharmacology studies for small molecule compounds in various stages of preclinical research and development in order to support H3 Biomedicine’s pipeline. Implements and manages studies with CRO and 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.
- Keep updated on new technologies that will enhance discovery toxicology capabilities and build scientific collaborations with internal or external partners.
- CRO selection and monitor the conduct of various in vitro and in vivo toxicology studies at selected CROs.
- 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).
- PhD in toxicology, pharmacology or related scientific discipline with 2-5 years of related experience (may include post doctorate experience) or Master’s level candidates with 5-10 years experience in the biopharmaceutical industry.
- Previous experience in the field of toxicology with direct involvement in designing, implementing, and analyzing preclinical toxicology studies (in vitro and/or in vivo) and relevant secondary/safety pharmacology studies to support research and/or clinical developmental candidates.
- Highly organized with strong problem solving and good time management skills
- Excellent written and verbal communication skills and strong interpersonal skills with an abilities to develop solid, long term relationships and to influence others.
- Experience working within a matrix working environment and a displayed willingness to adapt to rapidly changing priorities
About H3 Biomedicine Inc.
H3 Biomedicine Inc. is a privately-held, uniquely-structured oncology discovery enterprise whose sole mission is to become a prolific source of new drugs that treat more human cancers with greater success. H3 Biomedicine is applying the expertise of leading scientists to the integration of insights from cancer genomics with innovative capabilities in synthetic chemistry and tumor biology to pursue the most promising current opportunity in cancer therapeutics: patient-based, genomics-driven, small molecule drugs.