Topic: regulatory documents

Shape drug metabolism and pharmacokinetics strategy across therapeutic discovery programmes. This individual-contributor role designs and interprets in-vitro and in-vivo studies, guides candidate selection, oversees external research partners and contributes DMPK evidence to regulatory documents and cross-functional decisions.

Support clinical development of gene and base editing therapies through pharmacokinetic, pharmacodynamic and quantitative systems models. The role connects nonclinical and clinical analyses to study design, regulatory documents and programme decisions, and helps develop the clinical pharmacology function. It can emphasise pharmacometrics or combine pharmacometrics with clinical pharmacology. Based in Cambridge, Massachusetts.

Provide scientific and operational pharmacovigilance support for Beam’s therapeutic portfolio. Responsibilities span review of individual and cumulative safety data, signal assessment, risk management, aggregate safety reports and collaboration with clinical development teams. The director also oversees safety vendors and contributes to clinical and regulatory documents. The Cambridge role requires one to three days per week onsite.