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 Biomedicine is seeking an experienced toxicologist to establish a toxicology function that will provide support for Oncology drug discovery and development stage projects. The successful candidate will be responsible for the oversight of pre-clinical and development stage toxicology strategies in a multidisciplinary team environment. The successful candidate will be a key member of drug discovery and development teams providing safety target assessments and supervise toxicology studies in support of small molecule and antibody projects. In addition, the candidate will oversee the development of in vitro and/or in vivo models for hypothesis-driven, investigational and mechanistic toxicology studies.
Principal Duties and Responsibilities
- Provide strategic oversight for toxicology at H3 Biomedicine establishing department goals and tactical implementation of plans.
- Oversee quality and performance of all toxicology activities including interactions with alliance partners, CROs and external project support.
- Act as drug safety lead and ensure pathology support for drug discovery and development stage projects.
- Design and develop approaches for safety assessment of small molecule and antibody therapeutics for oncology drug discovery and development projects.
- Prepare and present internal and external documentation relating to nonclinical safety (e.g. IND, CTA, annual reports and IBs). Negotiate with health authorities worldwide regarding safety issues, scientific interpretation and suitability of sponsor’s data.
- Lead efforts to develop in vitro/in vivo model systems for hypothesis testing of project specific toxicology issues.
- Initiate and facilitate collaboration with academic centers, pathology and toxicology consultants as necessary to support internal infrastructure.
- PhD with minimum 10 years of experience in toxicology or related discipline in the pharmaceutical/biotech industry, leading and managing drug development projects. DABT board certification is a plus.
- Proven record in developing regulatory submissions including IND/CTA; interactions with health authorities and knowledge of regulatory guidelines regarding toxicology requirements enabling initial and continuing clinical studies.
- Knowledge of current existing guidelines, regulations, requirements and standards (GLP, ISO, OECD, ICH).
- A strong understanding of Oncology is required; experience in small molecule therapeutics required, antibody therapeutics is a plus.
- Extensive industry experience in investigational toxicology and an excellent understanding of early stage drug discovery and development processes.
- Board certification in pathology (DACVP) a plus.
- Ability to communicate clearly and effectively with project teams, management and CROs.
- Ability to work in a team environment, meet deadlines and prioritize and balance work from multiple groups.
- Independently motivated, detail oriented and good problem solving ability.
- Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with 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.