Lead Scientist; Senior Investigator/Associate Director – Clinical Biomarkers & Companion Diagnostics

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.

H3 Biomedicine is seeking a senior level scientist/associate director to lead the Clinical Biomarkers team. As part of the Biomarkers and Companion Diagnostics group, the clinical biomarkers team is accountable for developing and delivering of robust, scientifically-driven biomarker strategies in development programs for H3 Biomedicine’s unique portfolio of precision medicine oncology drugs. As the head of clinical Biomarkers is accountable for leading a small team of biomarker scientists and directly providing clinical biomarker strategy expertise and guidance to some drug projects.

Principal Duties and Responsibilities
  • Provide clinical biomarker strategy direction and leadership - individually and for the clinical biomarker operational team as a whole.
  • Develop biomarker strategies and ensuring delivery to oncology drug project teams following agreed plan.
  • Manage studies working closely with the Biomarker operations team, CROs, project teams and H3B teams to deliver biomarker data to support programs including: 1) Measuring target engagement to inform clinical decisions for selecting  therapeutically relevant doses and schedules. 2) Understanding key cancer pathway interactions and feedback mechanisms to guide rational drug combinations. 3) Generating biomarker data to guide indication selection and identification of targeted patient populations. 4) Defining mechanisms of resistance to treatment
  • Interface with internal functions and external companies to provide technical guidance in the development of biomarker assays and IVDs as needed.
  • Ensure complex clinical assays developed and validated internally or externally are fit for purpose
  • Lead the evaluation, validation and implementation of novel technologies and capabilities both internally as well as at CROs or external collaborators
  • Perform analysis of data and summarize results from experiments performed
  • Present key results at group meetings and to project teams, governance bodies and stake-holders
  • Contribute to and ensure the quality of clinical biomarker study reports, data reviews and interpretations, presentations, scientific publications and recommendations to project teams and H3B management.
  • Lead and mentor the clinical biomarker team: support recruitment and line management of employees, ensuring that they are appropriately trained, developed and coached to comply with company and regulatory standards. Actively contribute to the optimization of existing as well as the development of new processes to ensure best practice. Mentors and develop Biomarker scientists and provide feedback to head of the Biomarker and Companion Diagnostics group, as appropriate, on individual's performance.
  • MD, PharmD or PhD in a scientifically relevant discipline with 5-10 years industry or academic experience.
  • In-depth knowledge of oncology and translational science.
  • Significant experience working in oncology clinical research.
  • Experience in molecular biology and/or pathology highly desirable.
  • Thorough understanding of all aspects of oncology clinical drug development, proven experience in strategic planning, proven ability to understand and critically assess the global clinical development plans, protocol design, resources needs, budgets and timelines for programs applicable to clinical biomarker and companion diagnostic strategy.
  • Demonstrated leadership, influencing, communication and project management skills.
  • Ability to anticipate and solve problems.
  • Experience and desire to motivate and develop others.
  • Knowledge of IVD/drug co-development is a plus.
  • Although not mandatory, previous functional or line management (coaching, mentoring and developing staff) experience is a definite plus.
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.

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