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Associate Director/Director, Clinical Pharmacology

🏛️ Beamtherapeutics 📍 Cambridge, MA 🗓️ Posted 16 hours, 6 minutes ago
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About this role

Company Overview:

Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.

​Position Overview: ​

The Associate Director/Director in Clinical Pharmacology position will support a rapidly expanding clinical portfolio of promising gene/base editing therapeutics. The candidate in this position should have strong scientific and technical skills, be well versed in PK and PD with a strong ability to critically evaluate and interpret data, conduct rapid exploratory analysis, quantitative systems pharmacology (QSP) and PKPD modeling. In this role, the candidate is expected to have strong data analyses, modeling, and critical thinking ability with good oral and written communication skills. The role could be tailored to focus solely on pharmacometrics or could be a hybrid Clinical Pharmacology/Pharmacometrics role based on the candidate’s experience and career aspirations. As a member of the clinical pharmacology department, this person is expected to operationalize model-based drug development, by integrating modeling results into clinical study design, regulatory documents, and internal decision-making. ​

Responsibilities:

  • ​Provide critical input in build-out of the Clinical Pharmacology function, including hiring of personnel and deployment of modeling infrastructure.
  • ​Operationalize model-based drug development, including new methodology approaches as described in regulatory guidelines.
  • Serve as key functional expert to lead, direct, and coordinate the activities of their assigned modeling projects.
  • ​Conduct PK and PK/PD analyses and modeling using nonclinical and clinical data.
  • ​Contribute to protocol and study report writings.
  • ​Present key pharmacometrics analyses results to internal and external stakeholders.
  • ​Facilitate model-based drug development across to support BEAM’s clinical programs.
  • ​Develop and write pharmacometrics analysis plans, execute and author reports on results of analyses.
  • ​Define and drive pharmacometrics contributions to regulatory/submission strategy and related documents.
  • ​Provide strategic expertise and leadership for development programs based on relevant technical and disease area knowledge.
  • ​In collaboration with cross functional partners, provide support for the quantitative evaluation of competing trial/analysis strategies.
  • May manage portfolios at disease area/therapeutic area/indication level to support integration of pharmacometrics and relevant knowledge in the planning and execution of programs and strategies.
  • ​Preparation of abstracts and manuscripts for publications.

    Qualifications: