Entrada Therapeutics Benefits Overview

Leads planning, authoring, coordination, and submission support for regulatory documents across preclinical, clinical, and registration stages. Serves as lead author and document expert, manages external writing resources, represents Regulatory Writing on cross-functional teams, and develops SOPs, authoring guides, and project-management tools. Supports IND, CTA, CTR, and NDA submissions while ensuring quality, compliance, and timely delivery across the development portfolio.

Lead and support statistical strategy for clinical trials, author SAPs and regulatory documents, oversee outsourced CRO biostatistics deliverables (TFLs), review randomization procedures, and manage vendor relationships. Part-time long-term contract (~20-25 hours/week) supporting rare-disease programs and regulatory submissions.

Lead statistical strategy and oversight for clinical trial programs, produce and review SAPs, TFLs, randomization, CRFs, and regulatory submissions; manage outsourced CRO biostatistics, develop novel analytical methods, and contribute to departmental standards and cross-functional initiatives.