Teams at Entrada Therapeutics

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.

Leads and supports global clinical trial start-up and enrollment activities, including regulatory submissions, country and site selection, budgets, site activation, informed consent review, document collection, protocol amendments, CRO and vendor oversight, issue resolution, and study-specific training. Ensures deliverables meet timelines and comply with ICH, GCP, local regulations, and company procedures. This is a part-time, long-term remote contract role requiring approximately 10% travel.

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.