Head of Biomarker Operations

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 Biomarker Operations team. As part of the Biomarkers and Companion Diagnostics group, the Biomarker Operations team contributes to H3B development programs at a broad and strategic level by developing, implementing and overseeing the biomarker and companion diagnostics operations strategy in collaboration with the program biomarker leads and clinical study teams. As the head of biomarker operations you will lead a small team of biomarker scientists and directly provide biomarker operational expertise and guidance to some clinical programs.

Principal Duties and Responsibilities
  • Provides biomarker operational direction and leadership - individually and for the biomarker operational team as a whole.
    • Establish biomarker operational plans (timelines, resources, budget, analyze risk and quality) in collaboration with project biomarker leads that meets the project needs.
    • Ensure the timely and efficient delivery of all biomarker operational aspects to H3B clinical development programs.
    • Planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker samples (including companion diagnostic samples) (collection, processing, analysis, data delivery process and final sample disposition).
    • Develops and maintains effective working relationships clinical operational teams, diagnostic partners, external CRO & Central Lab (for outsourced teams), and external biomarker vendors.
    • Ensures study and biomarker operational adherence to ICH/GCP and SOPs.
  • Lead and mentor the biomarker operations 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 Operations staff and provide feedback to head of the Biomarker and Companion Diagnostics group, as appropriate, on individual's performance.
  • MS, PharmD or PhD in a scientifically relevant discipline with 5-10 years industry or academic experience.
  • Significant experience working in oncology clinical studies.
  • 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 biomarker operations strategy.
  • Demonstrated leadership, influencing, communication and project management skills.
  • Ability to anticipate and solve problems.
  • Ability to work independently with appropriate consultation as needed
  • 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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