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Head of Clinical Biomarkers

Company: Yoh, A Day & Zimmermann Company
Location: Cambridge
Posted on: February 20, 2021

Job Description:

Head of Clinical Biomarkers

LOCATION:-Cambridge MA

Our client is a leading company in cancer genomics driven drug discovery, delivering on the promise of precision medicine. Now with three clinical stage anti-cancer molecules in active development, they are 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. They embrace a novel business model in which it collaborates with another leading global pharmaceutical company, to create a prolific drug discovery engine and partnership platform.

They are 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 their 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 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 client 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.


    Qualifications


    • 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.


      -

      Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.PandoLogic. Keywords: Oncology Director, Location: Cambridge, MA - 02238

Keywords: Yoh, A Day & Zimmermann Company, Cambridge , Head of Clinical Biomarkers, Healthcare , Cambridge, Massachusetts

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