Location: Cambridge MA
Cambridge, MA-based H3 Biomedicine (H3B) 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 H3B’s robust discovery pipeline and clinical programs. Now with three clinical stage anti-cancer molecules in active development, H3B 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. H3B 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.
The H3B modeling and simulation scientist will be primarily responsible to deliver a quantitative and mechanistic understanding of PK/PD/efficacy relationships to support project teams from early discovery through early clinical development.
In addition, the individual will be involved in the design, execution, analysis, interpretation and communication of pharmacokinetics (PK) and absorption, distribution, metabolism, and excretion (ADME) studies of to support drug development from early discovery through preclinical and clinical development. The individual will serve as DMPK project representative to coordinate and lead all nonclinical DMPK activities on programs from the research phase through development. An individual with in-depth knowledge and expertise in PK/PD modeling and simulation and ADME would be essential.
Principal Duties and Responsibilities
- Deliver a quantitative and mechanistic understanding of PK/PD/efficacy relationships to support drug discovery and development teams
- Design and execute preclinical studies to understand the pharmacokinetics (PK) and absorption, metabolism, distribution, and excretion (ADME) of drug candidates
- Represent DMPK as the subject matter expert to H3B project teams, develop and drive DMPK and PK/PD strategy for Drug Discovery projects
- Responsible for the analysis, interpretation, integration and reporting of preclinical DMPK data generated both internally and with external vendors
- Participate in the management of CROs in the conduct of in vitro/in vivo ADME studies
- Partner with and support Drug Safety, Research, Clinical, Regulatory, Project Management and other departments
- PhD. in Pharmacokinetics, Pharmacology, Pharmaceutics or other relevant field with 5 years of experience in the biopharmaceutical industry preferred, or MS/BS with 5 years' industry experience, including modeling and simulation experience
- Conceptual fluency with modeling, and in depth hands-on modeling experience (e.g. using WinNonlin Phoenix, MATLAB/Simbiology, PK Sim, Simcyp, or, background using NONMEM to develop PK/PD models)
- Strong knowledge of drug metabolism, ADME concepts, pharmacokinetics, pharmacodynamic and bioanalytical principles is required.
- Experience with biologics desirable but not required.
- Strong communication (verbal and written) and presentation skills required
- Excellent interpersonal skills and ability to represent DMPK in a team environment are essential
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.