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Non-Clinical Development

Director, Preclinical Bioanalytics

  • Cambridge, MA
  • Added
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Position Overview:

The Director leads the development, transfer, and implementation of critical bioanalytical at CROs in support of Beam’s preclinical development programs and is a contributing member/leader of project teams. This person will provide scientific, technical, and strategic leadership in preclinical bioanalysis to support Beam’s portfolio. The Director will be responsible for selecting bioanalytical CROs to conduct pivotal preclinical bioanalytical work. Working closely with NCD Operations, Toxicology, and In-Vivo Biology, this person will be responsible for the timely execution of method qualifications and/or validations supporting pivotal preclinical studies and ensuring they are executed to appropriate guidances in a timely manner. The Sr/Director will be the single point of accountability for reviewing and approving all preclinical bioanalytical qualifications, validations, and sample analysis reports. 

This person works closely with the Analytical Sciences team to ensure bioanalytical methods required for development programs are developed and are ready for transfer to CROs for use in pivotal preclinical studies.  Additionally, the Director will work with the Clinical Bioanalytics team to keep them updated on preclinical method status and ensure a timely transition of preclinical methods to the Clinical team, as appropriate. The Director must be a highly motivated individual with a proven track record of scientific leadership, collaboration work, management experience and the development of junior team members.

Responsibilities:

  • Transfer bioanalytical methods to CROs to support pivotal non-clinical studies.
  • In conjunction with the project teams, determine the overall preclinical assay strategy for development programs.
  • Coordinate CRO and vendor selection (e.g. quotes, capabilities assessments, site audits), and in close collaboration with NCD Operations, oversee contracts/SOWs process.
  • Review and approve all bioanalytical qualification and validation protocols, reports, and related documentations.
  • Ensure delivery of high-quality bioanalytical data and regulatory documents (IND, BLA, global filings) as well as health authority interactions and scientific contributions.
  • Ensure regulatory compliance and scientific oversight of internal as well as external bioanalytical programs.
  • Manage timeline for delivery of assays, data and reports to support regulatory filings.
  • Leads project teams, and cross functional initiatives as needed.
  • Communicate results, progress and issues to project teams.
  • Develops and manages related fiscal budgets and planning processes.
  • Ensure new bioanalytical technologies are being assessed and incorporated when appropriate.
  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.

Qualifications:

PhD in scientific discipline with at least 10+ years of relevant experience in a biopharma/biotech setting, preferably in cell or gene therapy environment with increasing scientific and leadership responsibilities in regulated Bioanalysis and Bioanalytical strategy and implementation roles. 

  • Hands-on experience developing molecular biology, cell biology, biochemistry and immunology methods.
  • Thorough knowledge of assay development and validation under GLP, FDA, EMA, ICH and other applicable guidelines.
  • Experience coordinating and managing CROs and vendors under tight timelines.
  • Excellent organizational, planning, and multi-tasking skills.
  • Strong communication (oral and written) and interpersonal skills.
  • Experience across all phases of drug development required, experience in gene therapy or cell therapy drug development preferred.
  • History of conducting and overseeing the analysis of clinical and nonclinical samples for all therapeutic programs in a GLP laboratory.
  • Experience across all phases of large molecule drug development strongly desired.
  • Ability to manage bioanalytical development, optimization and qualification within a CRO or with CRO partners.
  • Ability to work collaboratively with stakeholders to resolve issues.
  • Experience in authoring and reviewing critical documentation including protocols and reports connected to assay development, validation and clinical sample testing, biomarker elements in IND filing documents.
  • Accustomed to working in a fast-paced, dynamic environment.
  • Demonstrated ability to manage complex projects and programs.
  • Detail-oriented with strong focus on accuracy, while still being able to see the big picture.


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