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Head of Clinical Assays and Biomarkers

Company: Beam Therapeutics Inc.
Location: Cambridge
Posted on: June 7, 2021

Job Description:

Beam is seeking a Clinical Assays and Biomarker Director to develop and drive biomarker strategy across our portfolio of next-generation gene editing therapies, working collaboratively with cross functional team members. The role will involve the establishment and management of a clinical assays and biomarkers team, which will liaise with external assay laboratories, collaboration partners and CROs. This position will work across several disease/program teams and associated compounds to ensure planning, execution and data delivery of the biomarker strategy plans and data for all clinical trials conducted by Beam. Additionally, the role will encompass the management of a team of direct and indirect reports.

Responsibilities:

  • With input from the research and clinical leads, evaluate technologies to identify, define and implement the biomarker strategy to support the clinical development of Beam's compounds
  • Drive the biomarker strategy to ensure assay labs complete appropriate qualification or validation work in order to execute on the clinical biomarker plan(s) on time and with appropriate quality standards
  • Ensure the timely and efficient delivery of all biomarker operational aspects across therapeutic area clinical trials
  • Accountable for planning, coordinating, and overseeing all operational activities required to manage the flow of biomarker samples from planning, collection, analysis, data delivery and final sample disposition
  • Serve as a single point of contact for biomarker operations across teams, and with collaborators, assay labs and CROs.
  • Responsible for the identification and selection of biomarker vendors in collaboration with the Translational Science/Research leads
  • Ensure collection, delivery and analysis of biosamples according to the protocol and in compliance with protocol, informed consent, local regulations as well as GCP/ICH
  • Develops and provides operational input and recommendations into all study related documentation (including protocol, informed consent form, and amendments) and processes.
  • Manage development and oversight of the biomarker analysis timelines, with respect to the budget, risk and quality plans
  • Attend operational team meetings, monitor trainings, CRO kick-off meetings, etc., to deliver insight and trainings on biomarker activities to appropriate parties
  • Contributes to biomarkers data interpretation and reporting.

Qualifications:

  • MD/Ph.D. or equivalent with minimum of 5 years or MA/MS with minimum 8 years of relevant experience in pharmaceutical industry setting in the application of biomarkers in clinical trials, preferably in Hematology, Oncology or Rare Diseases of the liver.
  • Proven track record of high-impact contributions to biomarker discovery and assay development
  • Experience in clinical translational or biomarker work and its role across drug development from early phase through licensure
  • Up to date knowledge and deep understanding of major molecular and genomic assay technologies and platforms
  • Knowledge and track-record of working to GCP principles
  • Strong sense of urgency and ability to thrive in a fast-paced, matrix environment
  • Excellent prioritization, planning and interpersonal skills
  • Experience in managing contract laboratories and budgets
  • Demonstrated scientific capability as evidenced by publications, research reports, and external presentations.
  • Effective verbal and written communication skills

Keywords: Beam Therapeutics Inc., Cambridge , Head of Clinical Assays and Biomarkers, Other , Cambridge, Massachusetts

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