Jobs 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.

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.

Manage and improve employee experience programs including onboarding, orientation, engagement surveys, and the Co-Op program. Partner with HR leaders on talent programs, performance cycles, employee relations, investigations, and HR projects. Coordinate learning and development initiatives, HR operations tasks, and maintain HR documentation and org data to support organizational effectiveness.